BARDA BAA-23-100-SOL-00004.pdf

Office of Biomedical Advanced Research and Development Authority (BARDA) Broad

Agency Announcement (BAA)

BAA-23-100-SOL-00004

BARDA 2023 BAA: Original Solicitation

September 26, 2023

Biomedical Advanced Research Development Authority (BARDA)

Division of Contract Management & Acquisition (CMA)

400 7th Street, SW, Washington, DC 20024

MedicalCountermeasures.gov https://www.medicalcountermeasures.gov/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 2 of 72

Table of Contents

INTRODUCTION

Disclaimers

OVERVIEW INFORMATION

Agency Name

Issuing Office

Development Opportunity Title

Announcement Availability

Eligible Offerors

Research and Development Opportunity Description

Research and Development Areas of Interest

Technological Maturity

Number of Awards

Type of Award

General Market Research (TechWatch Program)

Application Process

Submission Deadlines and Government Response Time

Contact and Submission Information

Electronic Portal Submission Instructions

Limitation on Communication After Submission

Special Instructions

Proposal Handling and Submission Information

BACKGROUND

Part I: Development and Technical Objectives

Program Management Approach

Regulatory Approach

Development and Manufacturing Approach

Part II: Reporting Requirements and Deliverables

Part III: Special Considerations

Contractor Responsibility Regarding Sensitive Information

BARDA BAA-23-100-SOL-00004 –Solicitation Page 3 of 72

Security Plan

Identification and Disposition of Data

Confidentiality of Information

Publications

Press Releases

Export Control Notification

Manufacturing Standards

Prohibition on Contractor Involvement with Terrorist Activities

Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions (Stages 1 & 2)

Stage 1: Pre-submission Call with Technical POC

Stage 2: Quad Chart and Market Research Abstract Preparation

Stage 2: Quad Chart and Market Research Abstract Submission

Part V: Quad Chart/Market Research Abstract Assessment

Part VI: Proposal Instructions (Stage 3)

Stage 3: Proposal Preparation

Stage 3: Proposal Submission

Part VII: Proposal Evaluation

1. Program Relevance

3. Offeror’s Capabilities and Related Experience, Including the Qualifications, Capabilities, and Experience of the Proposed Key Personnel

Other Evaluation Factors and Considerations

Evaluation Rating

Additional Information

Part VIII: Research and Development Areas of Interest

Area of Interest #1: CBRN Vaccines

Area of Interest #2: CBRN Antivirals and Antitoxins

Area of Interest #3: Antimicrobials

Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures

Area of Interest #5: Chemical Medical Countermeasures

Area of Interest #6: Burn and Blast Medical Countermeasures

Area of Interest #7: Diagnostics

BARDA BAA-23-100-SOL-00004 –Solicitation Page 4 of 72

Area of Interest #8: IEID Vaccines

Area of Interest #9: IEID Therapeutics

Area of Interest #10: ImmuneChip+

Area of Interest #11: COVID-19 Immune Assay(s) Development and Implementation

Area of Interest #12: Flexible and Strategic Therapeutics (FASTx)

Part IX: Appendix

Appendix 1: Government Notice for Handling and Submitting Proposals

Appendix 2: Cost Certification

BARDA BAA-23-100-SOL-00004 –Solicitation Page 5 of 72

INTRODUCTION

Within the Administration for Strategic Preparedness and Response (ASPR), the Office of Biomedical Advanced Research and Development Authority (BARDA) was established and mandated by Congress as the organization within the U.S. Government to catalyze innovation in advanced research and development (R&D), manufacturing, and procurement of Medical Countermeasures (MCMs). These lifesaving MCMs are needed to protect people during public health emergencies from threats such as chemical, biological, radiological, and nuclear (CBRN) incidents (whether accidental or intentional), pandemic influenza, COVID-19, and other emerging infectious diseases. BARDA works closely with interagency partners through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to ensure a coordinated, whole-of-Government approach to MCM preparedness and response.

The BARDA model has proven successful in leveraging public-private partnerships to accelerate development of MCMs that are vital to national security. BARDA helps its partners promote innovation and develop countermeasures from early research through U.S. Food and Drug Administration (FDA) approval and clinical application. Over the last 15 years, BARDA has supported over 80 FDA approvals, licensures, and clearances of MCMs.

The COVID-19 pandemic serves as a stark reminder of the need to protect individuals from public health emergencies. BARDA was critical in the development, manufacturing, and procurement of MCMs that saved countless lives during the pandemic. The COVID-19 pandemic revealed gaps and challenges at BARDA as noted in the BARDA Strategic Plan 2022-2026. Increasing the speed of partnering was identified as an area of improvement in the strategic plan.

To achieve objectives outlined in the BARDA strategic Plan, BARDA is modernizing the Broad Agency Announcement (BAA). The new BAA, BARDA BAA-23-100-SOL-00004, is designed to enable BARDA to accelerate partnering, improve responsiveness and meet expanding demand to develop MCMs. By releasing this BAA, BARDA seeks to improve efficiency, improve responsiveness, and decrease time to award, by modernizing our 15+-year BAA1 to meet the demands of an expanding mission and portfolio of industry partners. Change to this BAA reflects experience and growth of the acquisition vehicle and the need for BARDA to more quickly pivot and respond during a pandemic or public health emergency.

Disclaimers

This BAA, which sets forth R&D areas of interest (AOIs) for BARDA, is issued under paragraph 6.102(d)(2)(i) of the Federal Acquisition Regulation (FAR). Proposals selected for award are considered to be the result of full and open competition and in full compliance with 41 U.S.C. § 3301. A formal Request for Proposal will not be issued. Paper copies of this announcement will not be issued. The U.S.

Government (Government) reserves the right to select for award and fund all, some, or none of the proposals in response to this announcement. All proposals will be treated as sensitive competitive information and the contents only disclosed for the purpose of evaluation.

Offerors that are not responsive to the Government requests for information in a timely manner, defined as meeting Government deadlines established and communicated with the request, may be removed from award consideration.

The Government reserves the right to award the instrument best suited to the nature of the research proposed and may award any appropriate contract type including FAR-based contracts and Other Transactions, as well as grants and cooperative agreements.

Significant change compared to the prior BAA: Under this BAA, Stage 1 and Stage 2 submissions are considered market research, outside the scope of FAR Part 35, and used by BARDA to collect and analyze information about capabilities within the market to satisfy agency needs. Should the Stage 2 submission

1 BARDA’s BAA has been open continually under various forms and solicitation number since originally released in 2008.

https://www.medicalcountermeasures.gov/ https://www.medicalcountermeasures.gov/ https://www.medicalcountermeasures.gov/barda/fdaapprovals/ https://www.medicalcountermeasures.gov/barda/fdaapprovals/ https://www.medicalcountermeasures.gov/barda/strategic-plan/ https://www.acquisition.gov/far/6.102#FAR_6_102__d379e67 https://www.govinfo.gov/content/pkg/USCODE-2020-title41/html/USCODE-2020-title41-subtitleI-divsnC-chap33-sec3301.htm https://www.acquisition.gov/far/part-35

BARDA BAA-23-100-SOL-00004 –Solicitation Page 6 of 72 be assessed favorably, then the Respondent will be invited to submit a Stage 3 Proposal. Stage 3 proposals will be evaluated consistent with FAR Part 35. Further information regarding the three stages of this BAA process is discussed in Part IV through Part VII of this announcement.

https://www.acquisition.gov/far/part-35

BARDA BAA-23-100-SOL-00004 –Solicitation Page 7 of 72

OVERVIEW INFORMATION

Agency Name

U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Office of Biomedical Advanced Research and Development Authority (BARDA), 400 7th Street, SW, Washington, DC 20024

Issuing Office

Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research Development Authority (BARDA)/ Division of Contract Management & Acquisition (CMA), 400 7th Street, SW, Washington, DC 20024

Development Opportunity Title

Office of Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

Announcement Availability

This BAA is available on the following websites:

• SAM.gov

• MedicalCountermeasures.gov

• Grants.gov

Amendments to this BAA will be posted to the websites listed above when they occur. Interested parties are encouraged to check these websites periodically for updates and amendments.

Eligible Offerors

This BAA is open to ALL responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, and academic institutions and must be registered in the System for Award Management (SAM) at SAM.gov prior to receiving an award.

Federally Funded Research and Development Centers (FFRDCs) and Government entities (Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they address the following conditions. FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector AND must provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to Government solicitations and compete with industry, and compliance with the associated FFRDC sponsor agreement and terms and conditions. This information is required for FFRDCs proposing to be primes or subcontractors. Government entities must clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority (as well as, where relevant, contractual authority) establishing their ability to propose to Government solicitations. Specific supporting regulatory guidance, together with evidence of agency approval will be required to establish eligibility. BARDA will consider eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the Offeror.

Historically Black Colleges and Universities (HBCUs), Minority Institutions, Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUBZone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals.

https://sam.gov/ https://www.medicalcountermeasures.gov/ http://www.grants.gov/ https://sam.gov/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 8 of 72

In accordance with federal statutes, regulations, and HHS policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from the HHS.

Research and Development Opportunity Description

The Division of Contract Management & Acquisition (CMA) on behalf of BARDA will engage in market research and solicit proposals for the advanced R&D of MCMs for CBRN agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. BARDA anticipates that R&D activities awarded under this BAA will serve to advance candidate MCMs toward approval, licensure, or clearance by the FDA. This BAA will also serve to advance the knowledge and scientific understanding, including but not limited to candidates’ platform technologies, modeling and forecasting, and visual analytics.

The purpose of this BAA is to solicit proposals that focus on R&D in the solicited AOIs as described in Part VI of this announcement. The BAA does not support the acquisition of products or the construction of facilities.

Research and Development Areas of Interest

Development and technical objectives are described in Part I. Efforts proposed by Offerors may cover all aspects of MCM Advanced R&D, including but not limited to Nonclinical R&D, Process Development, Platform Development, Formulation, Manufacturing, and Clinical Evaluation.

Technological Maturity

Interested parties should identify in their Quad Chart and Market Research Abstract the current Technology Readiness Level (TRL) of their product, and the TRL identified should meet or exceed the requirements of the given Development AOI. Each Market Research Abstract and Proposal must also contain sufficient supporting information and data to justify the TRL rating. Criteria for determining the appropriate TRL for a product can be found in the BARDA BAA Toolkit. Note that all activities within a TRL (or sublevel) must be completed to have achieved that TRL status. TRL requirements for enabling technologies or products that are not directly applicable to the TRL criteria will be considered on a case-by-case basis.

Number of Awards

Multiple awards of various values are anticipated and are dependent upon the program priorities, proposals’ scientific/technical merits, how well the proposals fit BARDA’s AOI, and available funds.

Anticipated funding for the program is subject to congressional appropriations. The program funding is subject to change due to Government discretion and funding availability.

Type of Award

A contract award under this BAA may utilize Cost-Reimbursement, including Cost (C), Cost Sharing (CS), Cost-Plus-Incentive-Fee (CPIF), and Cost-Plus-Fixed-Fee (CPFF) Contracts, and Firm-Fixed-Price (FFP) type contracts.

Offerors submitting Proposals should submit CS contract (or C contract) proposals. When CS is proposed, the amount of cost participation should depend on the extent to which the R&D effort or results are likely to enhance the Offeror’s expertise, capability, or competitive position.

If an Offeror does not believe that a CS contract (see FAR 16.303) (or C contract [see FAR 16.302]) is appropriate, then the Offeror should provide (see B. Basic Cost/Price Information in Volume II – Cost Proposal Overview) an explanation (i) as to why there is no probability that the Offeror would receive any present or future benefits from an award, (ii) if the R&D is expected to be of only minor value to the Offeror, or (iii) if a statute precludes the use of cost sharing.

https://www.medicalcountermeasures.gov/barda/barda-baa#toolkit https://www.acquisition.gov/far/16.303 https://www.acquisition.gov/far/16.302

BARDA BAA-23-100-SOL-00004 –Solicitation Page 9 of 72

If the Government contemplates the award of a Cost-Reimbursement-type contract, the Offeror must demonstrate prior to award that its accounting system is adequate for administering a Cost- Reimbursement contract. Offerors should propose the type of arrangement they believe best satisfies the requirement.

The Government may also elect to make awards in the form of grants and cooperative agreements, and Other Transaction agreements, as authorized for BARDA under the Pandemic and All-Hazards Preparedness and Advanced Innovation Act of 2019.

The costs of preparing responses to this BAA are not considered an allowable direct charge on any resultant award.

General Market Research (TechWatch Program)

Offerors are encouraged to participate in the TechWatch program prior to any Market Research Abstract or Proposal submissions under this BAA. Participation in the TechWatch program affords Offerors an opportunity to present their capabilities to BARDA scientific subject matter experts and program managers, as well as CMA acquisition professionals, even if there is currently no relevant AOI open. These personnel can evaluate products/technologies, suggest techniques and strategies for meeting technical and regulatory challenges, provide insight on how a product or technology may address BARDA's objectives, and provide general information about BARDA's mission and programs. To request a TechWatch meeting and for more information about the TechWatch program, Offerors should visit the TechWatch website. Entities with a Market Research Abstract or Proposal currently under review under any ASPR solicitation are not eligible to schedule a TechWatch meeting related to that submission.

Application Process

Stage 1: The Government realizes that the preparation of a development proposal often represents a substantial investment of time and effort by the Offeror. To minimize this burden, BARDA encourages organizations and individuals interested in submitting proposals to make preliminary inquiries with the technical point of contact (POC) of the AOI as to the general need for the type of R&D effort contemplated before expending extensive effort in preparing a detailed abstract and proposal or submitting proprietary information. Refer to Part IV for instructions on requesting a pre-submission call.

Stage 2: Prepare a cover sheet, Quad Chart, and Market Research Abstract in accordance with the preparation guidance. Interested Parties must submit their Stage 2 submission documents in accordance with the instructions provided in Part IV. Stage 2 submission documents should describe the effort in sufficient detail to allow subject matter experts and program staff to assess the concept's technical merit and its potential contribution to the BARDA mission. BARDA will assess Market Research Abstracts based on the criteria provided in Part V.

Respondents whose Stage 2 submission receives a favorable assessment in the Market Research Phase will be invited via email to submit a Proposal in Stage 3. Respondents whose Stage 2 submission does not receive a favorable assessment will be notified via email and will be provided with information on technical issues and concerns that BARDA has regarding the proposed product. This written feedback is the only response that will be provided to unsuccessful Stage 2 Respondents.

Stage 3: Offerors must submit their Proposals in accordance with the instructions provided in Part VI.

Proposals will be evaluated against criteria as described in Part VII. Proposals that do not conform to the requirements outlined in the BAA or to the instructions provided in the invitation letter will not be considered for further action.

The application process is also described in the BARDA BAA Process Flow Chart (Figure 1) in Part IV.

https://www.medicalcountermeasures.gov/Request-BARDA-TechWatch-Meeting/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 10 of 72

Submission Deadlines and Government Response Time

TABLE 1: SUBMISSION DEADLINES AND GOVERNMENT RESPONSE TIME

Proposal Stage Deadline for Submission* Government Response

Stage 1: Pre-submission Call

A pre-submission call can be initiated at any time during the open period of the BAA.

Requests for pre-submission calls will be acknowledged via email within 1 week.

Stage 2: Quad Chart and Market Research Abstract

A Quad Chart and Market Research Abstract may be submitted at any time prior to the submission deadline, which is September 25, 2028, at 4:30pm Eastern Time.

An automated receipt confirmation will be sent upon submission to the BARDA Digital Resources (BDR) Portal.

A response will be provided within 120 days of the receipt of the submission.

Stage 3:

Proposal

As specified in the Invitation Letter.

A Proposal may be submitted on any day during the open period of the

BAA.

Proposal submission deadline is September 25, 2028, at 4:30pm Eastern Time.

An automated receipt confirmation will be sent upon submission to the BDR Portal.

A response will be provided within 120 days of the receipt of the submission.

Contact and Submission Information

Contractual: After a Market Research Abstract or Proposal has been submitted, all Contractual inquiries regarding this BAA must be sent to: BARDA-BAA@hhs.gov. Note: Offerors should not submit any proprietary information via this email, as all information received via this email is assumed non-proprietary. Offerors should submit any proprietary information via the BDR Portal only.

Technical: Technical questions only should be directed to the Technical POC listed under each AOI in Part VI. Contracting Officers will not be present during Stage 1 Pre-Submission Calls.

Submissions: All submissions, including the Market Research Abstract and Proposal, will only be reviewed after they are submitted in the BDR Portal.

Electronic Portal Submission Instructions

All submissions in response to this BAA must be sent via email to BARDA-BAA@hhs.gov (with a copy to BDR_Admin_Inbox@hhs.gov) until October 2, 2023, at which time all submissions must be submitted to the BDR Portal via the process described below.

Offerors will be required to register for a BDR Portal account before a Market Research Abstract or Proposal can be submitted. A BDR account can be requested by visiting the BDR Portal and following the applicable prompts.

The account request process is simple but may take several days for approval and access. Account requests will require the Respondent to enter a set of basic information (i.e., first and last name, email address, and phone number). Upon confirmation of a BDR Portal account, the Respondent will login using the prescribed two-factor authentication method. Once login is complete, the Respondent will be prompted to enter information about Respondent’s organization and to input the submission with other project-specific information.

mailto:BARDA-BAA@hhs.gov mailto:BARDA-BAA@hhs.gov mailto:BDR_Admin_Inbox@hhs.gov https://bdr.hhs.gov/ https://bdr.hhs.gov/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 11 of 72

If you experience any issues, please reach out to BDR_Admin_Inbox@hhs.gov. Failure to propose your submission on time for any reason (e.g., due to late registration in BDR Portal) will result in the submission not being considered for award. Respondents will be provided an automated confirmation of successful submission of either a Stage 2 Market Research Abstract or a Stage 3 Proposal.

All Stage 2 and Stage 3 submissions must be proposed electronically via the process described on the BDR Portal and in the following format:

• Single searchable PDF file

• Page Size: 8 ½ x 11” with 1” Margins

• Spacing – single

• Font – Arial, 11 point (use of Arial or another readable font and readable smaller size point in tables and captions will be accepted)

The file should not exceed 10 Megabytes of storage space. Movie and sound file attachments, URL Links, or other additional files, will not be accepted.

Limitation on Communication After Submission

Be advised that after a Market Research Abstract (or Proposal) has been submitted to the BDR Portal, all communications related to that submission must be through the Contracting Office at BARDA- BAA@hhs.gov. Communications following the Government response to a Market Research Abstract or Proposal submission must be through the Contracting Officer identified in the response letter. Please include the BDR Portal submission ID in your email for tracking purposes.

Special Instructions

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOIs and may have unique submission due dates. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall include the information requested therein.

Proposal Handling and Submission Information

Treatment of Submission Documents: All proposals are treated as Offeror’s proprietary information prior to award and the contents are disclosed only for the purpose of evaluation. The Offeror must indicate any limitation to be placed on disclosure of information contained in the proposal in accordance with the instructions as set forth in FAR 52.215- 1(e) “Restrictions on disclosure and use of data.”

Classified Submissions: Classified proposals will not be accepted. All submissions must be Unclassified.

Use of Color Proposals: All proposals received shall be stored as electronic images. Electronic color images require a significantly larger amount of storage space than black-and-white images. As a result, Offerors' use of color in proposals should be minimal and used only when necessary for details. Do not use color unless necessary.

Post-Employment Conflict of Interest: There are certain post-employment restrictions on former Federal officers and employees, including special Government employees (18 U.S.C. § 207). If a prospective Offeror believes a conflict of interest may exist, the situation should be emailed to the appropriate Contracting Officer, prior to expending time and effort in preparing a proposal. The appropriate HHS personnel will discuss any conflict of interest with the prospective Offeror.

Unsuccessful Proposal Disposition: The original of each proposal received will be retained by ASPR pursuant to FAR 4.805 and all other non-required copies destroyed.

Government Notice for Handling and Submitting Proposals: Refer to Appendix 1: Government Notice for Handling and Submitting Proposals for inclusion requirement of the Government notice.

mailto:BDR_Admin_Inbox@hhs.gov mailto:BARDA-BAA@hhs.gov mailto:BARDA-BAA@hhs.gov https://www.acquisition.gov/far/52.215-1#FAR_52_215_1__d3205e195 https://www.govinfo.gov/content/pkg/USCODE-2016-title18/html/USCODE-2016-title18-partI-chap11-sec207.htm https://www.acquisition.gov/far/4.805

BARDA BAA-23-100-SOL-00004 –Solicitation Page 12 of 72

BACKGROUND

This BAA sets forth advanced development AOIs for BARDA, a component of ASPR within the U.S.

Department of Health and Human Services (HHS). This BAA is issued under paragraph 6.102(d)(2) of the FAR, and proposals selected for award are considered to be the result of full and open competition and in full compliance with the Competition in Contracting Act of 1984, 41 U.S.C. 253.

BARDA is soliciting proposals for the advanced R&D of MCM for CBRN agents; the ever-present and ever -evolving threat of pandemic influenza; and the re-emergence and emergence of infectious diseases that threaten the U.S. civilian population.

• BARDA’s Division of CBRN Countermeasures is dedicated to development and licensure of MCMs to help the Nation prepare for, respond to, and recover from public health emergencies arising from naturally occurring and intentionally engineered threats. To achieve its mission of making available at least one MCM against every material threat, CBRN is pursuing a three-pronged strategy, which includes (1) investing in MCMs to treat the injury, not the threat, (2) developing innovative MCMs for unknown threats, and (3) delivering novel MCMs against bacterial and viral threats. For past investments, see CBRN’s MCM portfolio.

• BARDA’s Influenza and Emerging Infectious Diseases (IEID) Division uses a comprehensive portfolio approach to develop and acquire a broad array of MCMs for pandemic influenza and emerging infectious diseases. This includes efforts to accelerate and improve the development of vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures for influenza preparedness and to establish a sustainable end-to-end solution for vaccine domestic manufacturing infrastructure.

o The Pandemic Influenza Program is dedicated to supporting continued innovation and advancement in pandemic influenza preparedness. Strategic priorities include:

modernization of influenza vaccines; recombinant pandemic influenza vaccine development, including funding of ongoing clinical trials; development of faster platforms and more sustainable approaches for seasonal, pandemic, and emerging infectious diseases;

development of alternative delivery models; development of adjuvants, which can be used to increase the supply of pandemic influenza vaccine and may have the potential to enhance the efficacy of vaccines; and strengthening U.S.-based vaccine manufacturing.

o The Emerging Infectious Diseases (EID) Program invests in MCMs to address known and a wide range of emerging infectious diseases, including COVID-19, Ebola, Zika, pandemic influenza, and more. BARDA is investing in flexible agreements, platform technologies that result in faster development, programs that expand access to MCMs, sustainable approaches, improved delivery, and increased production capacity. For past investments in support of the Federal COVID-19 response, see BARDA's COVID-19 MCM portfolio.

• BARDA’s Detection, Diagnostics, and Devices Infrastructure (DDDI) Division funds the development of testing and medical device countermeasures, along with select cases for domestic manufacturing capacity, to produce them to address all threats in BARDA’s mission space: CBRN, influenza, and emerging diseases. Investment areas include home-use and point-of-care diagnostics, domestic test manufacturing expansion, rapid test availability in emerging disease outbreaks, rapid screening tests, threat-agnostic tests, and laboratory diagnostics.

• BARDA's Division of Research, Innovation & Ventures (DRIVe) seeks to accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats. DRIVe pushes innovation boundaries to tackle the biggest health security challenges while seeking new ideas and new approaches to prevent and protect against health security threats.

BARDA offers multiple core services to assist in the development and production of MCMs in a matter that is timely, reliable, and cost effective. Awards resulting from this BAA may benefit from these services, https://www.acquisition.gov/far/6.102#FAR_6_102__d379e67 https://www.medicalcountermeasures.gov/barda/cbrn/ https://www.medicalcountermeasures.gov/barda/cbrn#portfolio https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/ https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/PI.aspx https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/ https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx https://www.medicalcountermeasures.gov/barda/dddi/ https://drive.hhs.gov/ https://www.medicalcountermeasures.gov/barda/core-services/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 13 of 72 which include an animal study network, flexible manufacturing facilities, and technical expertise in development, manufacturing, regulatory affairs, quality systems, and clinical studies.

BARDA’s advanced R&D priorities and the requirements herein are driven by and closely aligned with other federal reports and strategic plans (Table 2). Refer to AOIs in Part VI for specific investment areas.

TABLE 2. DIVISION OR ORGANIZATIONAL-WIDE STRATEGIC DOCUMENTS

Document* Date of Publication

Relevant Program Areas

National Health Security Strategy 2023-2026 March 2023 All

National Biodefense Strategy October 2022 All

2022 PHEMCE Strategy and Implementation Plan October 2022 All

BARDA Strategic Plan 2022-2026 May 2022 All

White House’s American Pandemic Preparedness:

Transforming Our Capabilities

September 2021 All

National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), 2020-2025

October 2020 CBRN

National Influenza Vaccine Modernization Strategy (NIVMS) 2020-2030

June 2020 PI

HHS Pandemic Influenza Plan June 2017 PI

*Specific documents driving program requirements can be found in the respective AOIs in Part VI

For additional requirements information, visit:

• The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417 and 42 U.S.C. § 241 et seq.

(PAHPA).

• The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 113-5 (PAHPRA).

• The Pandemic and All-Hazards Preparedness and Advanced Innovation Act of 2019 Pub. L. No. 116-22 and 42 U.S.C. § 247d-7e (PAHPAIA).

Learn more about legal authorities, policies, and committees and strategies and reports for BARDA-supported MCMs.

https://aspr.hhs.gov/NHSS/National-Health-Security-Strategy-2023-2026/Documents/nhss-2023-2026-508.pdf https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf https://aspr.hhs.gov/PHEMCE/2022-SIP/Documents/PHEMCE-SIP-2022-508.pdf https://www.medicalcountermeasures.gov/barda/strategic-plan/#plan https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29 https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29 https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/196436/CARB-National-Action-Plan-2020-2025.pdf https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/196436/CARB-National-Action-Plan-2020-2025.pdf https://www.phe.gov/Preparedness/planning/nivms/Documents/nivms-2020-2030.pdf https://www.phe.gov/Preparedness/planning/nivms/Documents/nivms-2020-2030.pdf https://www.medicalcountermeasures.gov/BARDA/Documents/pan-flu-report-2017v2.pdf https://www.govinfo.gov/content/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf https://uscode.house.gov/view.xhtml?req=42+USC+241 https://www.govinfo.gov/content/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf https://www.congress.gov/bill/116th-congress/senate-bill/1379 https://uscode.house.gov/view.xhtml?req=42+USC+247d-7e https://aspr.hhs.gov/legal/Pages/default.aspx https://medicalcountermeasures.gov/federal-initiatives/strategies-and-reports/

BARDA BAA-23-100-SOL-00004 –Solicitation Page 14 of 72

Part I: Development and Technical Objectives

The information in this section is provided to assist and guide Offerors in preparing their Market Research Abstracts and Proposals Statements of Work (SOW). The topics listed below exemplify some of the typical activities undertaken during a drug, biologic, diagnostics, or device development effort in the areas of project management, clinical and nonclinical studies, manufacturing, and regulatory strategy. Offerors should address these in the Market Research Abstract in sufficient detail (within space limitation) to demonstrate that Offeror understands the scope of work needed. Offerors shall submit a SOW in their Proposal that addresses these topics as appropriate. Provide as much detail as may be necessary to fully explain and justify the proposed technical approach or method. In the event that an Offeror’s technical approach provides for performance in excess of one year, the SOW must be presented in discrete segments that are non-severable in their activity. Each segment must contain specific work elements that must be achieved to support go/no-go milestones that predicate execution of each subsequent option segment of the work.

Consequently, contracts awarded under this BAA may contain contract options that may be unilaterally exercised by the Government that either follow or run concurrently with a base period of performance.

The length of the base period of the contract is subject to negotiation. Offerors are invited to propose certain discrete stages or areas of work as contract options.

Offerors should propose a SOW consistent with activities for the TRL indicated for each Development AOI in Part VI. Development programs at a maturity level less than that indicated for each Development AOI should consider funding opportunities offered by the National Institute of Allergy and Infectious Diseases (NIAID) or other Federal agencies that fund earlier-stage R&D projects. Proposal preparation and submission instructions are contained in Part VI.

Program Management Approach

Market Research Abstracts and Proposals for all AOIs must address Program Management Activities, which may include but are not limited to:

• Identification and management of distinct stages of the product development pathway that are gates for Go/No-Go decisions for advancing to the next stage of the Integrated Product Development Plan;

• Establishment and tracking of milestones and timelines for the initiation, conduct, and completion of product development activities for each stage, with a budget (in direct costs) linked to each stage;

• Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development;

• Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work;

• Conducting performance measurement that shall include:

o establishing an initial plan;

o defining measurable parameters;

o defining how these parameters relate to cost and schedule impacts;

o approach in providing a detailed schedule that generates a critical path for the project; and o a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both prime- and sub-contractors on a real time bases;

• Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract; and

• Development of a risk evaluation and mitigation strategy for the overall project.

Regulatory Approach

Market Research Abstracts and Proposals for all AOIs must address regulatory activities, as appropriate for the MCM, which may include but are not limited to:

BARDA BAA-23-100-SOL-00004 –Solicitation Page 15 of 72

• A clear and comprehensive regulatory master plan that focuses on the crucial pathway integrating all products, risk evaluation and mitigation at all development stages, nonclinical and clinical testing, and manufacturing activities using the most current and available information, including documented and time-relevant consultation with FDA. Plan should include a tentative schedule for regulatory milestones;

• Establishment and filing of regulatory submissions to the correct office at the FDA;

• Maintenance of a plan for additional studies to support future filing for FDA approval/clearance;

• Development of a potential Plan for consideration of an Emergency Use Authorization (EUA) of a medical product when appropriate;

• Maintaining all required regulatory documentation (investigator brochure, regulatory binder, etc.)

providing periodic updates to the FDA as required and seeking FDA guidance on the conduct of studies that will be used to support approval/licensure/EUA; and

• Conducting site initiation, monitoring, and closeout visits to contract research organizations subcontracted to perform studies.

Development and Manufacturing Approach

Product development, including clinical/nonclinical studies and manufacturing activities, is listed here for Small Molecules and Biologics, including therapeutics), Vaccines, Diagnostics, and Respiratory Protective Devices.

Small Molecules and Biologics, Including Therapeutics

For Small Molecules and Biologics, the proposed development program should consist of these elements when applicable:

• Nonclinical Toxicology, PK, and Efficacy

• Clinical Evaluation

• Chemistry, Manufacturing, and Controls (CMC)

Nonclinical Toxicology, PK and Efficacy R&D Activities include but are not limited to:

• Evaluating the safety, toxicology, pharmacokinetics / pharmacodynamics, bioavailability, solubility, formulation, of the MCM using both in vitro and animal models following Good Laboratory Practice (GLP) guidelines (as described in 21 CFR § 58), as and when appropriate;

• Screening of small molecule libraries for antitoxin / antimicrobial / antiviral activities (for already approved or licensed product);

• Expand assessment of antiviral potential for therapeutics previously approved for other indications;

and

• Evaluating the immunogenicity, safety, efficacy, pharmacokinetics / pharmacodynamics, bioavailability, solubility, formulation, dose, route and schedule of the MCM using both in vitro and animal models following GLP guidelines (as described in 21 CFR § 58), as appropriate.

Clinical Evaluation Activities include but are not limited to:

• Design and conduct of Phase 1 clinical studies to evaluate the safety and pharmacokinetics of the therapeutic candidate/product in humans in accordance with Good Clinical Practice (GCP) guidelines for Investigational New Drug (IND) applications (as described in 21 CFR § 312 and International Council for Harmonization [ICH] Guidelines document E6);

• Design and conduct of a Phase 2 and/or Phase 3 clinical studies in accordance with all Federal regulations and GCP guidelines;

• Design and conduct of clinical trials to evaluate safety and/or efficacy of candidate products in at-risk populations (e.g., older adults, pediatric, or immunocompromised persons); and

• Design and conduct clinical trials to evaluate optimal use of influenza antivirals or immunomodulators for informing clinical and public health management decisions.

CMC Activities include but are not limited to:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312 https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice

BARDA BAA-23-100-SOL-00004 –Solicitation Page 16 of 72

• Development of master and working cell banks under current Good Manufacturing Practice (cGMP) guidelines (as described in 21 CFR § 211);

• Process development activities to increase efficiency, yield, quality, and reduce the variability and risk factors in the manufacture of the drug substance and drug product;

• Formulation development to evaluate combinations of excipients and their influence on the Target Product Profile (TPP) and on product stability;

• Manufacture of Good Manufacturing Practice (GMP) and of non-GMP pilot lots of candidate product in amounts sufficient to carry out required/proposed nonclinical and Phase 1 and/or Phase 2 clinical trials;

• Identification of critical quality attributes and critical process parameters;

• Manufacturing scale-up plan to lead to consistency lot manufacturing of the candidate product;

• Process flow for personnel, material and waste disposal;

• Proposed packaging design and execution of fill-finish process of final drug product;

• Design of stability testing plan and conduct of stability studies on bulk and final product;

• Manufacturing/Testing facility plan to support Phase 1 through commercial scale product supply;

• Development of analytical methods and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and stability of the bulk drug substance and final drug product. Offerors shall identify a stable source and availability of reagents and reference standards for these assays required;

• Development of Validation Protocol for stability-indicating analytical and assay methods to define product manufacturing control, performance, potency, and stability;

• Development of processes that would benefit from alternative manufacturing or analytical techniques using continuous manufacturing (e.g., continuous perfusion, continuous synthesis, non-column based chromatography), if applicable;

• Integration of continuous mode(s) into manufacturing process and the development of in-line process analytical technologies, if applicable;

• Continuous processing for homogeneous production of final dosage forms (e.g., tableting, strip film manufacturing system, injection molding, and printing) if applicable;

• Development of Risk Evaluation and Mitigation Strategies (REMS) or similar risk mitigation strategy proposals; and

• Manufacturing/Testing facility plan to support clinical trial lots through commercial scale product supply, including consideration of a surge in manufacturing capacity in the event of a pandemic (e.g., influenza).

Vaccines

For vaccines, the proposed development program should consist of these elements when applicable:

• Nonclinical

• Analytical Assays

• Clinical Evaluation

• CMC

Nonclinical Activities include but are not limited to:

• Limited evaluation in ancillary nonclinical studies as required to support proposed activities with a maturity of TRL 6 or greater.

Analytical Assays Activities include but are not limited to:

• Development of analytical methods and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and stability of the bulk drug substance and final drug product. Offerors shall identify a stable source and availability of reagents and reference standards required for these assays; and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

BARDA BAA-23-100-SOL-00004 –Solicitation Page 17 of 72

• Development of Validation Protocol for stability-indicating analytical and assay methods to define product manufacturing control, performance, potency, and stability.

Clinical Evaluation Activities include but are not limited to:

• Design and conduct of clinical trials to evaluate candidate MCM and device products in humans in accordance with GCP guidelines (as described in 21 CFR § 312 and ICH Guidelines document E6).

Clinical trial activities can be conducted at domestic or international sites, given appropriate justification.

• Design and conduct of clinical trials to evaluate safety and/or efficacy of candidate products in at-risk populations (e.g., older adults, pediatric, or immunocompromised persons).

• Evaluation and validation or correlation of clinical and/or immunological endpoints to support the development of broadly reactive vaccines (e.g., “universal” influenza vaccines), including innate and adaptive immunity, both humoral and cellular.

• Development of a clinical development plan that outlines key milestones and activities to mature the candidate product through FDA approval/licensure.

CMC Activities include but are not limited to:

• Development of master and working cell banks under cGMP guidelines (as described in 21 CFR § 211, 21 CFR § 600, and 21 CFR § 610);

• Process development activities to increase efficiency, yield, and quality, and to reduce the variability and risk factors in the manufacturing of the drug substance and drug product;

• Formulation development to evaluate combinations of excipients and their influence on the TPP and on product stability;

• Continuous processing for homogeneous production of final dosage forms (e.g., tableting, strip film manufacturing system, injection molding, and printing), if applicable;

• Manufacture of GMP lots of candidate products in amounts sufficient to carry out required/proposed clinical trials that would seek to enhance the effectiveness of existing biologics and pharmaceuticals;

• Identification of critical quality attributes and critical process parameters;

• Manufacturing scale-up plan to lead to consistency lot manufacturing of the candidate product;

• Process flow for personnel, material and waste disposal;

• Proposed packaging design and execution of fill-finish of final drug product;

• Design of stability testing plan and conduct of stability studies on bulk and final product;

• Development of REMS or similar risk mitigation strategy proposals; and

• Manufacturing/Testing facility plan to support clinical trial lots through commercial scale product supply, including consideration of capacity for surge manufacturing in the event of a pandemic (e.g., influenza).

Diagnostics

For Diagnostics, the proposed development program should consist of these elements when applicable:

• Product Development

• Manufacturing Development

• Clinical Evaluation

Product Development Activities include but are not limited to:

• Perform natural/case history studies of threat agent(s), if needed;

• Review the pathology of human disease related to threat agent(s);

• Identification of diagnostic markers of disease for threats of interest, if needed;

• Performance of human or non-GLP animal studies to demonstrate the clinical relevance, performance, and/or diagnostic utility of biomarkers;

• Performance of appropriate studies to demonstrate acceptable clinical performance of the assay with specimens and specimen volumes relevant to diagnostic intended use;

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312 https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-610

BARDA BAA-23-100-SOL-00004 –Solicitation Page 18 of 72

• Development of assays, reagents, devices, instruments, and consumables, or components thereof, necessary to perform diagnostic tests, either manually or with automated means. This includes the development of tooling and processes necessary to produce these products;

• Development of verification and validation protocols and execution of these protocols to prove performance of products developed;

• Identification of reference standard for use in validation and/or verification;

• Development of requirements that incorporates all potential users and environments of use for the product;

• Development of design control documents using an FDA-compliant Quality Management System

(QMS);

• Development of a product risk evaluation and mitigation strategy; and

• Production of non-GMP-compliant prototypes and reagent lots at laboratory scale.

Manufacturing Development Activities include but are not limited to:

• Identifying/developing pilot…