HHS-NIH-NIAID-BAA2020-1.pdf

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2020 Omnibus Broad Agency Announcement:

No. HHS-NIH-NIAID-BAA2020-1

Solicitation Issue Date: January 3, 2020

Participating NIAID Divisions: Division of Allergy, Immunology, and Transplantation (DAIT);

Division of Microbiology & Infectious Diseases (DMID)

Issuing Office: Office of Acquisitions, DEA, NIAID, NIH

5601 Fishers Lane, Room 3D38, MSC 9821, Bethesda, MD 20892-9821

Issuing Contracting Officer: Swee L. Teo teosl@niaid.nih.gov

(240) 669-5173

This solicitation contains opportunities to submit a proposal under the following distinct Research Areas, which are identified below:

RESEARCH

AREA

NIAID

DIVISION

TITLE PAGE NO. PROPOSALS DUE

001 DAIT Development of

Radiation/Nuclear Medical

Countermeasures (MCMs)

5 04/09/2020*

DMID

Advanced Development of

Vaccine Candidates for Acute

Flaccid Myelitis Associated with Enterovirus D68

02/28/2020*

Vaccine Candidates for

Biodefense and Emerging

Infectious Diseases

04/09/2020 *

Development of Therapeutic

Products for Biodefense, Anti-

Microbial Resistant (AMR)

Infections and Emerging

Diagnostics for Biothreats and

Emerging Infectious Diseases

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein. Please see the

Proposal Submission Instructions for more information.

Offers will be valid for 240 days unless a different period is specified by the Offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

mailto:teosl@niaid.nih.gov

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2020 Omnibus Broad Agency Announcement

No. HHS-NIH-NIAID-BAA2020-1

TABLE OF CONTENTS

SECTION 1 - Broad Agency Announcement Information…………………………………………………… p. 3

SECTION 2 - Contracting Officer Points of Contact………………………………….……………………... p. 4

SECTION 3 - Research Areas and Technical Objectives…………………………………….……………… p. 5

3.1 – Division of Allergy, Immunology, and Transplantation (DAIT)

3.1.1 - Background……………………………………………………………………………… p. 5

3.1.2 - Research Areas

3.1.2.1 - Research Area 001: Development of Radiation/Nuclear Medical Countermeasures

(MCMs)…………………………………………………………………………………….. p. 6

3.1.3 – Research Area 001: Additional Technical Proposal Instructions ……………………….. p. 9

3.1.4 – Research Area 001: Reporting Requirements and Deliverables ………………………. p. 15

3.2 – Division of Microbiology and Infectious Diseases (DMID)

3.2.1 - Background……………………………………………………………………………… p. 17

3.2.2 - Research Areas

3.2.2.1 - Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid

Myelitis (AFM) Associated with Enterovirus D68 ……………………………………………. p. 17

3.2.2.2 - Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases………………………………………………………………… p. 19

3.2.2.3 - Research Area 004: Development of Therapeutic Products for Biodefense, Anti-

Microbial Resistant (AMR) Infections and Emerging Infectious Diseases ……..……………. p. 22

3.2.2.4 - Research Area 005: Advanced Development of Diagnostics for Biothreats and

Emerging Infectious Diseases ……..……………………………………………………………… p. 35

3.2.3 – Research Areas 002, 003, and 004: Additional Technical Proposal Instructions ……... p. 25

3.2.4 – Research Areas 002, 003, and 004: Reporting Requirements and Deliverables ………. p. 30

3.2.5 – Research Area 005: Additional Technical Proposal Instructions ……………………… p. 37

3.2.6 – Research Area 005: Reporting Requirements and Deliverables ………………………. p. 43

SECTION 4 - Instructions, Conditions, and Notices to Offerors…………………………………………… p. 48

4.1 - General Instructions to Offerors………………………………………………… ………........... p. 48

4.2 – General Information…………………………………………………………………………….. p. 51

4.3 – Instructions to Offerors ………………………………………………………………………... p. 53

4.3.1 - General Information………………………………………………………………......... p. 53

4.3.2 - Technical Proposal Instructions ……………………………………………………...... p. 60

4.3.3 - Business Proposal Instructions ……………………………………………………….. p. 90

SECTION 5 – Special Contract Requirements …………………………………………………………. p. 106

SECTION 6 - Evaluation Factors for Award ………………………………………………………… p. 131

SECTION 7 - Attachments………………………………………………………………………………. p. 140

SECTION 1. - BROAD AGENCY ANNOUNCEMENT INFORMATION

You are invited to submit a proposal in accordance with the requirements of this BROAD AGENCY

ANNOUNCEMENT (BAA). The BAA is governed by Federal Acquisition Regulation (FAR) 6.102 and FAR

35.016, as well as the NIH Policy Manual, Chapter 6035, Broad Agency Announcements. A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature, identifying areas of research interest, and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

This solicitation contains multiple distinct Research Areas. Offerors may submit a proposal in response to one, or more, of the Research Areas contained herein. Offers submitted in response to this BAA must present separate detailed technical and business proposals designed to meet the Technical Objectives described for each Research Area proposed. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the Offeror, not the

Government.

Proposals are NOT evaluated against each other since they are not submitted in accordance with a common

SOW issued by the Government. Instead, Research and Technical Objectives are provided in the BAA that describe individual Research Areas in which the Government is interested. Proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified in this announcement.

The Government reserves the right to conduct discussions with all, some, one, or none of the proposals received in response to this BAA. If discussions are conducted, NIAID reserves the right to suggest modifying, adding or deleting milestones, decision points, research plans, processes, schedules, budget or product. The Government also reserves the right to make awards without discussions. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award. Multiple awards are anticipated. The selection for award under this BAA will be based upon the evaluation factors, importance to the agency programs, and the availability of funds.

SECTION 2. - CONTRACTING OFFICER POINTS OF CONTACT

This BAA contains Research Areas issued by multiple Divisions within the National Institute of Allergy and

Infectious Diseases. The Contracting Officer (CO) points of contact for questions related to specific Research

Areas issued by the Division of Allergy, Immunology, and Transplantation (DAIT) and Division of

Microbiology and Infectious Diseases (DMID) are identified below:

Division of Allergy, Immunology, and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen

Contracting Officer

Phone: (240) 669-5144

E-mail: Liem.Nguyen@nih.gov

Division of Microbiology and Infectious Diseases (DMID)

Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis

(AFM) Associated with Enterovirus D68

Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and

Emerging Infectious Diseases

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant

(AMR) Infections and Emerging Infectious Diseases

Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious

Diseases

Swee L. Teo

Contracting Officer

Phone: (240) 669-5173

Email: teosl@niaid.nih.gov mailto:Liem.Nguyen@nih.gov mailto:teosl@niaid.nih.gov

SECTION 3. - RESEARCH AREAS AND TECHNICAL OBJECTIVES

3.1 - DIVISION OF ALLERGY, IMMUNOLOGY, AND TRANSPLANTATION (DAIT), NIAID

3.1.1 - BACKGROUND

World events have highlighted the growing threat of chemical, biological, and/or radiological/nuclear weapons terrorism and its many forms, including the 1995 Tokyo sarin gas attack, radiological dispersal devices (dirty bombs) planted in Chechnya in 1995 and 1998, and the deliberate spread of anthrax spores and ricin through the United States postal service in 2001 and 2003. Acts of radiological or nuclear terrorism could involve the use of stolen or improvised nuclear devices, attacks on nuclear power plants or reactors, the detonation of a dirty bomb, or the placement of radiation sources in public locations or in food or water supplies. Moreover, natural disasters like the 2011 earthquake and tsunami in Japan which resulted in damage to the Fukushima Daiichi Nuclear Power Plant and release of radiation into the environment, have increased awareness of radiation exposure to civilians.

Radiation/nuclear incidents and disasters can potentially result in the exposure of large civilian populations to a high dose of radiation in a short period of time. Depending on the dose of whole-body exposure to external radiation, biological effects can range from acute effects, including nausea and vomiting within hours, hematopoietic and gastrointestinal injuries leading to immunosuppression, infection, hemorrhage and death within days to weeks (acute radiation syndrome, ARS), to late-term pulmonary, cardiovascular, and renal complications months after irradiation (Delayed Effects of Acute

Radiation Exposure or DEARE).

The United States Government recognizes the need to develop medical countermeasures (MCMs, e.g.

drugs, biologics) to address the systemic damage from radiation exposure following a radiation/nuclear incident. To this end, the Project BioShield Act of 2004, “Project BioShield”, Public Law 108-276, was enacted on July 21, 2004. This Act provides the Department of Health and Human Services (HHS) with authorities to procure MCMs for the Strategic National Stockpile (SNS) and to perform advanced research and development on priority MCMs against chemical, biological, radiological, and nuclear threats. Under this act, the NIAID Radiation and Nuclear Countermeasures Program (RNCP) was charged by HHS, on behalf of the National Institutes of Health (NIH), to address radiation-induced injuries resulting from a radiological/nuclear incident, with funds provided from a special congressional appropriation.

The coordinated efforts to support radiation research and development by the NIH, as well as other HHS sister agencies, are outlined in the HHS Public Health Emergency Medical Countermeasures Enterprise

(PHEMCE) Strategy and Implementation Plan. The NIH is committed to accelerating the development of drugs and biologics to treat injuries and for triage use in mass casualty situations. NIAID/RNCP supports advanced development and deployment efforts to make these medical countermeasures available for possible procurement by the Biomedical Advanced Research and Development Authority and subsequent storage in the SNS, under the aegis of the Office of the Assistant Secretary for

Preparedness and Response.

In 2005, based on the recommendations of a Blue Ribbon Panel, NIAID published its Strategic Plan and

Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats (and 2012 update). These plans describe a multifaceted program to expand research infrastructure and radiobiology expertise, promote the development of biodosimetry methods to assess radiation injury, and research, identify, develop, and obtain licensure for MCMs to mitigate or treat radiation-induced injuries, in order to save lives during a radiation emergency.

file:///C:/Users/lnguyen/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/VCSNHKPE/the%20HHS%20Public%20Health%20Emergency%20Medical%20Countermeasures%20Enterprise%20(PHEMCE)%20Strategy%20and%20Implementation%20Plan file:///C:/Users/lnguyen/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/VCSNHKPE/the%20HHS%20Public%20Health%20Emergency%20Medical%20Countermeasures%20Enterprise%20(PHEMCE)%20Strategy%20and%20Implementation%20Plan https://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf https://www.niaid.nih.gov/sites/default/files/radnucstrategicplan.pdf https://www.niaid.nih.gov/sites/default/files/radnucprogressreport.pdf

The goal of this BAA is to support the development of safe and effective MCMs to mitigate and/or treat tissue injuries resulting from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in radiation-associated morbidities and mortalities.

Given the extent of damage sustained after a mass casualty incident, drugs are not expected to be mobilized from the SNS before 24 hours, hence the need for MCMs that are efficacious 24 hours or later post-exposure.

Since the program’s inception, NIAID/RNCP has sponsored early-stage/applied research, product development programs, and targeted initiatives focused on development of drugs to mitigate or treat complications of ARS and DEARE. Investment in this portfolio has led to the establishment of several rodent and non-human primate animal models, which are critical for licensure of radiation mitigators under the U.S. Food and Drug Administration (FDA) Animal Rule. Studies funded by the RNCP that led to FDA approval include Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for the hematopoietic-ARS indication in March 2015 and November 2015, respectively. Although progress has been made in licensing products to treat some forms of radiation injury, drugs are still needed to address other forms of hematopoietic injury, as well as other organ systems affected by radiation exposure, such as the gastrointestinal tract, lungs, skin, kidney, and cardiovascular and central nervous systems.

3.1.2 - RESEARCH AREAS

3.1.2.1.1 – Budget and Award Information

NIAID estimates that the average annual total cost of up to $2 million (direct and indirect costs combined) per contract for the non-severable base period and each option period. However, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The total performance period comprised of the base and any options proposed by an Offeror should not exceed 3 years. It is the intent of NIAID to award to projects that address radiation syndromes other than hematopoietic acute radiation syndrome.

Awards are anticipated to be made in or around April 2021.

3.1.2.1.2 – Technical Objectives

The scope of this work to be funded under this BAA is the development of MCMs.

Offerors are invited to submit proposals to advance the development of one lead candidate MCM that has already demonstrated concept feasibility. MCM drug candidates should increase survival by mitigating and/or treating acute or delayed radiation injury.

Proposals must include a plan to conduct translational research and development and, if applicable, provide additional information and data to support U.S. FDA approval or licensure and submission

3.1.2.1 - Research Area 001 – Development of Radiation/Nuclear Medical

Countermeasures (MSMs) of an Investigational New Drug (IND) application. Offerors must provide a well-defined product development path towards approval following the FDA Animal Rule for mitigation or treatment of radiation-induced injury that includes IND-enabling studies that will be performed under the contract.

Specifically, this BAA is intended to support the research and development of promising new approaches to mitigate or treat tissue injuries arising from exposure to ionizing radiation, which may include: biologics (e.g., cytokines and free radical scavengers), cellular therapies; and drugs (e.g, anti-inflammatory agents, antibiotics, and anti-fibrotics). This solicitation will not support the development of biodosimetry biomarkers and/or devices to detect ionizing radiation exposure, unless the biomarkers are being developed to assess the biological effects and efficacy of the lead

MCM.

3.1.2.1.3 – Technical Approach

The lead MCM to be supported by this initiative should be easy to distribute and use in a mass casualty incident (e.g., the preferred routes of administration are oral, subcutaneous, inhalation, transdermal or intramuscular); cellular therapies, which may require intravenous administration, will be supported. In addition, the lead MCM must meet all of the following scientific and technical requirements prior to submission of the proposal:

1. The lead MCM must already have demonstrated efficacy (i.e., demonstrate clinically-relevant and statistically significant reduction in mortality and/or major morbidity in animal models of acute or delayed radiation injury predictive of the human response) when administered at least

24 hours after radiation exposure.

2. The lead MCM must be previously identified as having a favorable safety profile using animal model safety studies and/or in human clinical studies for another indication, in cases where appropriate biodosimetry is not available to confirm the radiation dose received prior to initiating treatment.

3. The lead MCM must have a target product profile, including:

a. Preliminary data to support the selection of the MCM, specifically: animal studies that demonstrate efficacy when delivered 24 hours or later after radiation exposure using appropriate animal models and assays.

b. Safety studies.

c. The intended use/indication of the lead MCM and the biodefense/public health gap that the product is intended to fill.

d. The performance specifications and features that the MCM will meet in order to provide therapeutic benefit.

e. In addition, include the following information, if available:

i. Pharmacokinetics/pharmacodynamics (PK/PD) studies.

ii. Physicochemical characteristics, current formulation, and a mechanism of action.

iii. Documentation of communications with the FDA’s Center for Drug Evaluation and

Research (CDER), Center for Biologics Evaluation and Research (CBER) or Center for

Devices and Radiological Health (CDRH) that are relevant to development activities for the proposed therapeutic product.

This contract will support the following activities:

1. Non-clinical Research and Development, including:

a. Development of animal models suitable for consideration under the FDA Animal Rule.

b. Reagent and assay development, including biomarkers to assess the biological effects and efficacy of the lead MCM.

c. Efficacy studies in animal models of radiation exposure to optimize the route of administration, formulation, dose, and dosing schedule when administered at least 24 hours or later after radiation exposure. Studies should be designed to be suitable (species, endpoints, measurements) for predicting future pivotal Good Laboratory Practice (GLP) efficacy studies under the FDA Animal Rule (21 CFR 314.600-314.650, 601.90- 601.95).

d. Mechanism of action studies as well as studies to identify, quantify and better understand secory radiation efficacy endpoints.

e. GLP and non-GLP toxicology and pharmacology safety studies, including bioavailability;

pharmacokinetic; and Adsorption, Distribution, Metabolism, and Excretion (ADME) studies.

f. Ex vivo studies using human samples.

2. Manufacturing, including:

a. Formulation development, stability, and production scale-up.

b. Physicochemical and bioanalytical methods development.

c. Current Good Manufacturing Practice (cGMP) and non-GMP manufacturing development and scale-up support of lead candidate in amounts sufficient to carry out the proposed non-clinical research.

d. Stability studies.

3. Other IND or New Drug Application (NDA) and Biological License Application (BLA) activities, including:

a. Development and drafting of Phase 1 human safety and pharmacokinetic study protocols.

b. Regulatory efforts to support pre-IND interactions with the FDA, drafting of an IND, and preparation of IND package.

c. Quality control over the implementation, coordination and conduct of the proposed activities.

d. Drug Master File submissions under cGMP guidelines. (see 21 CFR 314.420)

e. Discussions with the FDA’s CDER or CBER related to development for the proposed therapeutic product.

NOTE: Research and development studies are anticipated to advance MCMs toward submission of an IND application and eventual approval/clearance from the FDA under the FDA Animal

Rule (21 CFR 314.600- 314.6R50, 601.90-601.95). For more information please see the

Animal Rule Guidance and Biomarker Qualification Guidance provided by the FDA.

This contract will NOT provide funds to support the following activities:

1. Screening activities to identify new MCMs.

2. Performance of clinical trials (all phases).

3. Development of more than one lead candidate MCM per proposal.

4. Development of biodosimetry biomarkers and/or devices, unless the biomarkers are being developed to assess the biological effects and efficacy of the lead MCM.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf https://www.fda.gov/media/119271/download

5. Studies using fractionated radiation exposures, commonly used for clinical radiotherapy treatments, unless information gained would be directly applicable to an unintentional exposure scenario.

- END OF RESEARCH AREA 001 – TECHNICAL DESCRIPTION –

3.1.3 – RESEARCH AREA 001: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The following information supplements Section 4 – Instructions, Conditions, and Notices to Offerors, of this solicitation, and should be used for preparing proposals in response to Research Area 001. Separate and distinct proposals must be submitted for each Research Area to which you are proposing. It is recommended that your proposal be organized in accordance with the order of your SOW and the technical evaluation criteria provided in Section 6.

Additionally, your Technical Proposal shall address the following:

3.1.3.1 – Experimental Plan

NIAID recognizes that the regulatory path to licensure for products within the scope of this BAA may not have been previously defined. The regulatory requirements are likely to be defined in an iterative decision-making process with the FDA based on product-specific data as it emerges.

Provide an Experimental Plan that details the specific tasks and stages that the Offeror proposes to perform with contract funding that can reasonably be completed in three years.

The Experimental Plan must also include:

a. A description of how the lead MCM meets the technical requirements outlined in the Research and Technical Objectives section.

b. Documentation that the offeror has intellectual property (IP) protection and/or proprietary freedom to use all components and develop the proposed MCM, including bringing to FDA licensure and commercialization. Include letters from the IP-holder stating that they will provide the agent(s), any limitations on the studies to be performed with that agent(s), agreement about public disclosure of results (including negative results), and whether there are any agreements already in place.

c. Details of the critical path to licensure for the proposed product, based on current data and/or discussions with the FDA. Specify the elements of this critical path that would be completed under the proposed SOW. Describe any relevant FDA communications about the lead MCM

(this information should not exceed more than 1 page).

d. Activities and stages of product development that the Offeror proposes to perform under contract funding, including Go/No Go decisions for advancement to the next stage.

e. Timelines for the initiation, conduct and completion of product development activities for each stage, the analysis of outcomes and findings, and the preparation of detailed reports summarizing the results of work completed and an analysis of the data as it relates to the qualitative and quantitative criteria established for Go/No Go decision making. Provide a Gantt chart of proposed activities.

f. A detailed discussion of the proposed technical approach for each activity to be performed to achieve the project objectives, containing sufficient detail to fully explain and justify the scientific and technical rationale for the proposed approach and methodologies. When applicable, also include: (i) detailed information on radiation dosimetry and irradiator set-up

(e.g., radiation dose and quality, dose rate, source, geometry of irradiation); (ii) plans to ensure the correct dose is delivered (e.g. frequency of dosimetry calibration, in-run dosimetry (if appropriate). Radiation exposure type, dose level, and dose rates proposed for the study must be relevant to a terrorist incident or accidental exposure.

g. An analysis of risks that could compromise performance of activities described in the SOW, along with a risk mitigation plan in the event that the specified risks materialize.

h. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex. Further information regarding NIH expectations for the consideration of sex as a biological variable is provided at the following website:

http://orwh.od.nih.gov/sexinscience/overview/pdf/NOT-OD-15- 102_Guidance.pdf

i. Inclusion of vulnerable special populations (e.g., pediatrics and geriatrics) in the research plan, including the development of appropriate animal models to test the efficacy of the lead MCM, if applicable.

3.1.3.2 – Regulatory Compliance, Quality Control, Assurance, Data Management

Describe the organization’s programs to manage data, assure data quality, and comply with the needs of regulatory agencies.

a. Include a description of: (1) proposed data management that will be used for all studies; (2) the procedures for the data entry and validation; (3) documentation of data corrections, routine maintenance and backup, transmission of data, data reporting and exporting system, access control and confidentiality, and data retrieval and disaster recovery; and (4) the statistical design and analysis resources that will be used to support contract activities.

b. Describe procedures to be used to maintain documentation adhering to FDA regulatory standards and published guidance documents, for the conduct of assays under GLP and manufacturing under cGMP standards. Include information on data management for GLP and cGMP activities (as appropriate to the SOW).

c. Describe processes and procedures for regulatory compliance including: timing of audits, timely scheduling of audits, performance of audits, responding to audit reports and supporting documentation, as well as an audit history of the facilities proposed for use in carrying out contract activities (as appropriate to the SOW).

3.1.3.3 – Organizational Experience

In addition to the information requested under Section 4, Part 4.3.3. Business Proposal Instructions, paragraph 4.3.3.1.15, Qualifications of the Offeror, all offerors are requested to include in their technical proposals a description of at least two examples of similar projects performed by your organization that are of comparable size and scope and/or related to the effort proposed in response to this BAA. The projects may be either completed or ongoing.

http://orwh.od.nih.gov/sexinscience/overview/pdf/NOT-OD-15-102_Guidance.pdf http://orwh.od.nih.gov/sexinscience/overview/pdf/NOT-OD-15-102_Guidance.pdf

3.1.3.4 – Scientific and Technical Personnel

Provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of the proposed SOW. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the contract.

1) Principal Investigator (PI): Describe the experience, training, expertise, and qualifications, and level of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under the proposed SOW. In particular, address scientific and technical expertise in radiation biology and product development. Document the experience of the PI with performing studies of comparable size and scope (completed or ongoing) in accordance with FDA regulations and published guidance documents as appropriate to the proposed SOW.

2) Other Key Scientific and Technical Personnel: Describe the experience, training, expertise and qualifications, as well as the level of effort, for all proposed key scientific and technical personnel. In particular, address scientific and technical expertise in radiation biology, radiation dosimetry, and product development. Include the qualifications of the staff that will oversee radiation dosimetry and irradiator set-up.

3.1.3.5 – Project Management

1) Provide a Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks identified in the proposed SOW. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).

2) Provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants. Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Include a chart of the proposed organizational/management structure for the project.

3) Describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. The plan must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

4) Outline how the PI (or Project Manager) will communicate with the Contracting Officer’s

Representative (COR) and CO and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

3.1.3.6 – Facilities, Equipment, and Other Resources

The Technical Proposal should document availability and adequacy of facilities, equipment, space and other resources necessary to carry out the proposed SOW, including:

1) Location and features of facilities including a floor plan and a list of equipment and resources dedicated to the project for the prime contractor and any proposed subcontractors (lease or ownership information should be provided).

2) Provide procedures to be utilized to ensure compliance with all safety guidelines and regulations, including training and monitoring of personnel.

3) Document entry access to facilities of the contractor or the subcontractor, if any, for performing assays and animal studies under GLP standards and production of therapeutic material under cGMP guidelines as required by the Experimental Plan. Describe provisions for complying with

Public Health Service and Department of Agriculture guidelines and regulations for the housing and humane care and use of laboratory animals as prescribed by the Office of Laboratory

Animal Welfare (OLAW), the USDA Animal Welfare Act and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), if appropriate.

4) Identification and description of ALL support resources (including Information Technology systems) that will be required to effectively complete the proposed SOW.

5) Describe provisions for ensuring safe facilities for the conduct of work and the controls and provisions to be in place for handling radioactive materials and irradiation equipment.

3.1.3.7 – Uniform Cost Assumptions

Offerors should use the following assumptions for the purposes of estimating costs and preparing the technical proposal:

1) Technical Cost Assumptions

A. Business Proposals must provide a breakdown by line item cost, including: Direct Labor, Direct Materials, Animal costs (including housing), Subcontracts, Consultants, Travel (refer to the instructions in Section 4 - Business Proposal Instructions, of this solicitation).

B. It is anticipated that this contract will be aligned with the deliverables identified in the

Research and Technical Objectives. Consequently, Business Proposals must provide a breakdown of costs for each milestone as well as a cost estimate for the entire project period of performance. The Business Proposal must also include a detailed Gantt chart that provides timelines delineating each milestone and associated tasks, subtasks and budgets to the subtask level of detail.

2) Travel

A. Contract Initiation Meeting (base period):

Assume one meeting in the Rockville, Maryland area within 60 calendar days of the effective date of the contract to discuss contract initiation. Assume that this meeting will require a two-night stay and attendance of all of the Contractor’s key personnel (up to 5 individuals), including subcontractor’s personnel.

B. Annual Meetings (base period and options):

1. Annual Site Visits:

Assume annual 1-day site visits at the Contractor’s facilities to be attended by the

Principal Investigator and key personnel of the Contractor, Government personnel and 4 collaborators and/or key personnel of subcontractors. Travel and per diem costs for the

Government personnel shall not be included in the contract proposal.

2. Annual Programmatic Meetings:

Assume annual ½ day programmatic meetings, to be held in the Rockville, MD area.

Include travel costs (transportation, meals, hotel, etc.) for Contractor staff members, https://olaw.nih.gov/ https://olaw.nih.gov/ https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_program_information https://aaalac.org/ https://aaalac.org/ including the Principal Investigator, key coinvestigators, collaborators and subcontractors

(up to 5 individuals).

C. Scientific Meetings (base period and options):

Budget travel costs (transportation, meals, hotel, etc.) for one 3-day scientific meeting per year for up to 2 personnel to travel to present scientific findings generated under this contract.

D. Subcontractor Site Visits (base period and options):

Budget travel costs (transportation, meals, hotels, etc.) for two 2-day trips per year for up to

3 personnel to visit sites of subcontracts, if applicable.

3) Government Furnished Property

A. No Government Furnished Property is offered for this acquisition.

B. The purchase of Government Furnished Property will not be authorized as a direct charge under the resultant contract.

4) Options

Each Option must be budgeted separately within the Business Proposal. Uniform cost assumptions associated with Options are described in Section 3.1.3.7 above.

3.1.3.8 – Post-award Requirements

3.1.3.8.1 - Communication and Contract Review Meetings

This section of the Technical Proposal should document how the Offeror will ensure compliance with the post-award activities described below.

1. Collaborations:

Contractors will collaborate with other contractors awarded through this solicitation, including sharing of novel research reagents and other resources.

2. Contract Initiation and Annual Review Meetings:

Contractors are required to attend a contract initiation meeting and annual review meetings thereafter.

Initiation Meeting: The purpose of the contract initiation meeting is to introduce the projects, facilitate scientific discussion, and establish working relationships.

Annual Meetings: The COR will plan, conduct and be responsible for logistical arrangements for an annual review meeting to be held at a site chosen by the COR. Contractor PIs, Project

Managers, key personnel (including subcontractor personnel), the COR, and other designated

NIH staff will attend these meetings. The COR may invite other Government staff to attend these meetings.

Contractors shall provide:

• Updates on results of activities undertaken or completed since the last review meeting.

• Updates on the predicted timeline, including an updated Gantt chart.

• A description of any problems encountered or anticipated and approaches to overcoming them.

• A description of activities to be undertaken in the coming year.

The Contractor shall provide a copy of any slide presentations to the COR no later than 3 days after the annual meeting.

3. Site Visits:

The CO or COR may conduct site visits at the Contractor site(s) annually or as needed. The

Contractor shall plan, conduct and be responsible for the logistical arrangements for site visit meetings at the Contractor’s facility. The PI, Project Manager, key contractor and subcontractor personnel, the COR, and other designated NIH staff, shall attend the meetings unless directed otherwise. The Contractor shall provide a copy of any slide presentations to the COR no later than 3 days after the meeting.

4. Teleconferences:

The Contractor shall plan and conduct monthly teleconference meetings with the COR, and other designated NIH staff, during the contract period of performance, to discuss technical progress and financial invoices. Three days prior to the teleconference, the Contractor shall submit an agenda to the COR. Within one week after the teleconference, the Contractor shall provide a meeting summary of the teleconference to the COR. The timing of the teleconference meetings may be altered or adjusted by the COR as needed to address progress on the contract.

5. Additional Contract Meetings/Teleconferences:

The PI, Project Manager, key contractor and subcontractor personnel shall attend additional meetings or teleconferences at the request of the COR. Such meetings will be requested, as necessary, to discuss contract-specific issues and to review recommended changes or deviations from milestones and timelines in the SOW.

6. Meetings with the FDA:

The Contractor shall forward the dates and times of any meetings with the FDA regarding activities supported by the contract to the CO and COR and arrange for NIH staff to attend. The

Contractor shall provide the COR with documentation supplied to the FDA in advance of these meetings, as well as the final draft minutes of any meeting with the FDA.

7. Audit Reports:

Within thirty calendar days of completion of an audit related to conformance to FDA regulations and guidance, including adherence to GLP, cGMP or GCP guidelines, the

Contractor shall provide the COR with copies of the audit report and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, cGMP or GCP guidelines as identified in the final audit report.

3.1.3.8.2 - Contractual Commitments

Upon award of a contract, the contractor shall be required to make legal commitments through acceptance of Government contract clauses contract. The outline that follows is illustrative of the types of provisions required by the Federal Acquisition Regulations that shall be included in the contract. This is not a complete list of provisions to be included in contracts, nor does it contain specific wording of these clauses. Copies of complete terms and conditions applicable to your contract will be provided during negotiations.

1) Inspection: Work performed under the contract is subject to Government inspection and evaluation at all times.

2) Termination for Convenience: The Government may terminate the contract at any time for convenience if it deems termination to be in its best interest, in which case the contractor will be compensated for work performed and for reasonable termination costs.

3) Disputes: Any dispute concerning the contract that cannot be resolved by agreement shall be decided by the CO with right of appeal.

4) Equal Opportunity: The contractor will not discriminate against any employee or applicant for employment because of race, color, religion, sex, or national origin.

5) Gratuities: The Government may terminate the contract if any gratuities have been offered to any representative of the Government to secure the contract.

6) American-made Equipment and Products: When purchasing equipment or products under a contract award, the contractor shall purchase American-made items whenever possible.

7) Termination for Default: The Government may terminate the contract for default if the contractor fails to perform the work described in the contract and such failure is not the result of excusable delays.

8) Contract Work Hours: The contractor may not require an employee to work more than eight hours a day or forty hours a week unless the employee is compensated accordingly (i.e., overtime pay).

9) Covenant Against Contingent Fees: No person or agency has been employed to solicit or secure the contract upon an understanding for compensation except bona fide employees or commercial agencies maintained by the contractor for the purpose of securing business.

10) Patent Infringement: The contractor shall report each notice or claim of patent infringement based on the performance of the contract.

3.1.4 – RESEARCH AREA 001: REPORTING REQUIREMENTS AND DELIVERABLES

3.1.4.1 – Reporting Requirements

In addition to reporting requirements and deliverables identified elsewhere in this solicitation, it is expected that awards resulting from this Research Area will include the following reports and deliverables:

a. Quarterly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months.

b. Annual Progress Report

This report includes a summation of the results of the entire contract work for the period covered.

An Annual Progress Report will not be required for the period when the Final Report is due. A

Quarterly Progress Report shall not be submitted when an Annual Progress Report is due.

c. Final Report

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. An Annual Progress Report will not be required for the period when the Final Report is due.

The Contractor shall provide the COR and CO with an electronic copy of the Final Report in draft form in accordance with the DELIVERIES Article in SECTION F of this contract 30 calendar days prior to the completion date of this contract. The COR will review the draft report and provide the CO with comments within 15 calendar days after receipt. The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph.

d. Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

e. Other Reports and Deliverables

Other Reports and Deliverables may be required. This may include special reports required by regulation or policy and deliverables such as data, vaccine, etc. These will be developed after proposal receipt as a result of finalization of the SOW during negotiations. Special instructions, if applicable, will be provided to offerors in the Attachment entitled “Additional Technical

Proposal Instructions.”

3.1.4.2 – Deliverables

Delivery of other reports and deliverables will be proposed by the offerors in their technical proposal. They will be developed further after receipt of proposals as a result of finalization of the

SOW and other terms and conditions of any resultant contract during negotiations. Specific instructions, if applicable, will be provided to offerors in the Attachment entitled “Additional

Technical Proposal Instructions.”

All electronic reports and deliverables shall be submitted through the NIAID Electronic Reports and

Deliverables System, available here: https://erds.niaid.nih.gov/.

-- END OF SECTION 3.1 – DIVISION OF ALLERGY, IMMUNOLOGY, AND

TRANSPLANTATION (DAIT) –

3.2 - DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES (DMID), NIAID

3.2.1 - BACKGROUND

Research supported by the NIAID, NIH, Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID also has a key role in the development of new medical countermeasures (MCMs) against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. Through a variety of research grants and contracts, NIAID’s DMID supports basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics targeting multiple pathogens, including NIAID Category A, B, and C priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens).

NIAID/DMID intends to use this Broad Agency Announcement to help address goals articulated in a number of strategic plans. The National Biodefense Strategy (https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf) articulates the need to enhance preparedness through medical countermeasures, including vaccines, therapeutics and diagnostics.

The World Health Organization (WHO) has prioritized diseases with epidemic potential and for which there are no or insufficient countermeasures (https://www.who.int/blueprint/priority-diseases/en/), as well as bacteria for which new antibiotics are urgently needed

(https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed). Similarly, CDC has highlighted threats for which antimicrobial resistance is concerning, serious or urgent https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf.

Through this solicitation, NIAID aims to advance research and development of promising new therapeutics, vaccines and diagnostics addressing infections caused by these pathogens, as specified in the research topics described under the four Research Areas below.

3.2.2 - RESEARCH AREAS

3.2.2.1.1 – Budget and Award Information

NIAID estimates that one or more awards may be issued across Research Area 002 for a total cost of up to $3 million for the non-severable base work across all contracts (direct and indirect costs

3.2.2.1 - Research Area 002 – Advanced Development of Vaccine

Candidates for Acute Flaccid Myelitis (AFM) Associated with

Enterovirus D68 https://erds.niaid.nih.gov/ https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf https://www.who.int/blueprint/priority-diseases/en/ https://www.who.int/blueprint/priority-diseases/en/ https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf combined), depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. The total cost for each award(s) may vary depending upon the scope of the project and the technical objectives of the award(s).

The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. The total performance period comprised of the base and any options proposed by an Offeror should not exceed five (5) years which includes stability studies.

It is anticipated that the final vaccine drug product will be available to support a clinical trial with a target of completion before Aug 2022. Given the need to develop the vaccine candidate at a rapid pace, NIAID assumes the offeror will need to perform many activities in parallel to address the shortened timeline. Consequently, an abbreviated number of options are assumed but detailed costs are required for activities within the base and options.

Awards are anticipated to be made in or around October 2020.

3.2.2.1.2 – Technical Objectives

Recurring spikes in Acute Flaccid Myelitis (AFM) cases have recently been associated with

Enterovirus D68 (EV D68) outbreaks. Based on past outbreaks of AFM, NIAID anticipates that another outbreak will occur Aug-Dec 2020 and subsequently in Aug-Dec 2022.

Consequently, NIAID seeks to advance vaccine candidates for EV D68 into a Phase I clinical trial in anticipation of these next outbreaks. NIAID anticipates this initial clinical trial to be in healthy adults, as a first step to eventual use in pediatric populations.

The objective of Research Area 002 is to support the development of a candidate vaccine for EV

D68 associated AFM. The primary vaccine candidate requested is an inactivated EV D68 vaccine; however, other technologies to develop a non-replicating EV D68 vaccine will be considered (e.g., VLP). Proposed inactivated EV D68 vaccines most likely will require an adjuvant using either a single vaccine vial format or a combination two vial antigen plus adjuvant format that uses bedside mixing.