Amendment Five HHS-NIH-NIAID-BAA2020-1.pdf

HHS-NIH-NIAID-BAA2020-1 Page 1 of 7 Amendment Four (5)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT Five (5)

OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D38, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2020-1

Date of Solicitation Issuance: January 3, 2020

Date of Amendment Five (5) Issuance: February 24, 2020

Number of Pages: 7

Proposal Due Dates:

The hour and date specified for receipt of offers for each Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE RECEIPT DATE AND

TIME

001 DAIT Development of Radiation/Nuclear Medical Countermeasures (MCMs)

3:00 PM Eastern Time, 04/09/2020

002 DMID Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68

3:00 PM Eastern Time, 02/28/2020

003 DMID Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

004 DMID Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

005 DMID Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

Points of Contact:

Division of Allergy, Immunology, and Transplantation (DAIT) Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen, Contracting Officer Email: liem.nguyen@nih.gov Phone: 240-669-5144 mailto:liem.nguyen@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 2 of 7

Division of Microbiology and Infectious Diseases (DMID) Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis 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

Primary Contact:

Swee L. Teo, Contracting Officer Email: teosl@niaid.nih.gov Phone: 240-669-5173

Secondary Contact:

Brian Madgey, Contracting Officer Email: brian.madgey@nih.gov Phone: 240-627-3712

Offerors MUST acknowledge receipt of the amendment by Amendment number (s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF SOLICITATION AMENDMENT

The purpose of Amendment Five is to:

I) Add a deadline for submission of Attachment 1 – Proposal Intent Response Form - for Research

Areas 003, 004, and 005.

II) Provide responses to questions received regarding the solicitation.

The responses are offered for information only and do not modify or become part of this solicitation.

Additional amendments may be provided as needed to address further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

mailto:teosl@niaid.nih.gov mailto:brian.madgey@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 3 of 7

I. Deadline for Submission of Attachment 1 – Proposal Intent Response Form for Research Areas 003, 004, and 005.

Division of Microbiology and Infectious Diseases (DMID) Research Areas 003, 004, and 005:

While not a requirement or binding, the NIAID kindly requests offerors who intend to submit a proposal in response to Research Areas 003, 004, and 005 to send the intent form, Attachment 1 of the BAA, no later than March 09, 2020. The NIAID uses the intent notice as a planning tool for proposal evaluation.

Please be sure to clearly identify the Research Area # that your organization is applying for on the intent form. Please send forms to Swee Teo at teosl@niaid.nih.gov.

II. The Government’s responses to questions received regarding this solicitation are as follows:

Division of Allergy, Immunology and Transplantation (DAIT)

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

Question 1: Section 3.2.3.2 indicates a Work Plan is required for Research Areas 002, 003 and 004 however, the Sample Statement of Work lists Work Plan as one of the requirements.

Could the government please clarify whether a Work Plan is needed for Research Area 001?

Response 1: No Work Plan is required for Research Area 001.

Question 2: Would the government confirm a detailed Gantt Chart of project activities need to be provided in both technical and business proposals?

Response 2: Yes, as stated in Section 3.1.3.1 – Experimental Plan, e., page 10/142, and Section 3.1.3.7 –

1) Technical Cost Assumptions, item B. (page 13/142), offerors are requested to provide the Gantt chart in both technical and business proposals.

Question 3: Would the government clarify what is a detailed task-linked budget? Does it mean a detailed budget with a cost breakdown (direct costs, indirect costs, and fees) required for the individual tasks/project activities associated with the Gantt Chart?

Response 3: A detailed budget with a cost breakdown (direct costs, indirect costs, and fees) is required for the individual tasks/project activities associated with the Gantt chart.

Question 4: Is the contractor allowed to use its own budget template for the detailed costs/task linked budgets while providing the cost breakdown of the summary budget in the same format as the budget template provided in attachment 9?

Response 4: Offerors are required to use the budget template provided in attachment 9 to reflect the total costs over the period of performance of the proposed contract. However, offerors can use their own budget template to prepare the detailed costs/task link budgets.

Question 5: According to FAR 15.403-1, Certified cost or pricing data shall not be obtained for acquisitions at or below the simplified acquisition threshold which has increased to $2 million effective July 1, 2018. Since the average annual total costs for research area 001 is up to $2 million per contract, mailto:teosl@niaid.nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 4 of 7 would the government confirm no certified cost or pricing data is required for research area 001?

Response 5: Please refer to Federal Register regarding a proposed rule by the Defense Department, General Services Administration, and the National Aeronautics and Space Administration on 10/02/2019 to amend the Federal Acquisition Regulation (FAR) to implement a section of the National Defense Authorization Act for Fiscal Year 2018 to increase the threshold for requiring certified cost or pricing date, to $2 million. Link provided below:

https://www.federalregister.gov/documents/2019/10/02/2019-20797/federal-acquisition-regulation-modifications-to-cost-or-pricing-data-reporting-requirements.

For DHHS, the Simplified Acquisition threshold is at $250,000.

Question 6: Would the government confirm no certified cost or pricing data is required for a subcontractor whose price is not expected to exceed the appropriate threshold set forth at FAR 15.403- 4, which was amended to $2 million on July 1, 2018?

Response 6: Per FAR Clause 15.403-4 (a)(1) the threshold for obtaining certified cost or pricing data is $750,000.

Question 7: In order to be compliant, would the government consider providing a complete list of minimum documentation requirements for cost data and all cost related support?

Response 7: Please refer to SECTION 4 – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, page 49/142 of the solicitation, for detailed information.

Question 8: Would the government confirm “the same format as the offeror’s cost proposal” means the same format for the cost details/breakdown instead of the entire package of business proposal with all the requirements/attachments?

Response 8: Subcontractor(s)’ cost proposal must have the same format for the cost details/breakdown, including budget justification and certificate of current cost or pricing data.

Question 9: What should be on the first page of the pricing proposal, the NIH 2043 form or the first page with all required information listed (1-10) on page 91)?

Response 9: NIH form 2043 should be on the first page.

Question 10: Will published preclinical evidence with a drug candidate be acceptable to reference as part of the application?

Response 10: On Page 8 of the solicitation, Section 3.1.2.1.3 – Technical Approach, The BAA states:

“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.”

The BAA does not preclude the use of other supportive data.

https://www.federalregister.gov/documents/2019/10/02/2019-20797/federal-acquisition-regulation-modifications-to-cost-or-pricing-data-reporting-requirements https://www.federalregister.gov/documents/2019/10/02/2019-20797/federal-acquisition-regulation-modifications-to-cost-or-pricing-data-reporting-requirements

HHS-NIH-NIAID-BAA2020-1 Page 5 of 7

Question 11: Will evidence in models of radiation be acceptable if the models are local forms of radiation, i.e. lung focal radiation?

Response 11: The BAA does not specify which animal models are acceptable for evidence of efficacy, but the MCM will need to show “statistically significant reduction in mortality and/or major morbidity in animal models of acute or delayed radiation injury predictive of the human response.” Page 8, Paragraph

1. of the 3.1.2.1.3 – Technical Approach section.

Division of Microbiology and Infectious Diseases (DMID)

GENERAL QUESTIONS

Question 1: Would it be acceptable to provide the Clinical Trial Protocol Development and Implementation synopsis as an appendix?

Response: Yes. However, the technical proposal shall not exceed 150 pages. Pages in excess of this limitation will be removed from the proposal and will not be considered. Please refer to Section 4.3.2.1.3.

Question 2: If no live animal use is proposed, would a statement in the technical response to the effect that no live animal use is proposed be considered acceptable towards satisfying this requirement.

Response: Yes, it would be non-applicable.

Question 3 If proposed agent/categories of experiments are not listed in the Dual Use Research of Concern (DURC) policy, would a statement in the technical response to the effect that no agent/categories of experiments listed in DURC is proposed be considered acceptable towards satisfying this requirement?

Response: Yes, it would be non-applicable.

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

Question 1: Given the urgency of the situation and a need for the quick development of a vaccine against COVID-19 (2019 novel coronavirus), would government consider expediting the decision for an award for proposals addressing development of a vaccine against COVID-19?

Response: NIH procedures and Section 6 of the BAA requires the technical merit of all proposals received for Research Area 003, including COVID-19, to be evaluated by a peer review group. Therefore, the NIAID cannot commit to an expedited decision for award. The Government may accelerate awards for COVID-19; however, we are not obligated to do so.

Question 2: Reference: 3.2.2.2.5 - Contracts awarded under this Research Area will NOT support: Basic research and discovery of new series/candidates/products.

Does the criteria, underlined above, apply to a proposal for a vaccine against COVID-19?

Response: Yes, contracts awarded under this Research Area will not support basic research and discovery of new series/candidates/products.

HHS-NIH-NIAID-BAA2020-1 Page 6 of 7

Question 3: Amendment 3 updated some of the requirements for Research Area 003, specifically the following is stated: “However, the vaccine platform utilized should be well developed with clinical experience, and a defined and scalable manufacturing process that is suitable for use in a global pandemic.” Is this statement specific to those vaccines targeting the 2019 Coronavirus, or for all vaccines responding to Area 003?

Response: The language was added for COVID-19 proposals with the goal of soliciting proposals that used mature technologies suitable for response and use in a global pandemic to offset the lack of early proof of concept data, critical reagents, and critical assays. Non-COVID-2019 Vaccines for Pandemic Preparedness proposals would implicitly include a “vaccine platform…(that) should be well developed with clinical experience, and a defined and scalable manufacturing process that is suitable for use in a global pandemic.”

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

Question 1: We have devised our project in periods with milestones in between that do not align with 12-month (yearlong) periods. For example, the first phase of our project is completed in 18 months, with milestones every 6 months. Can periods rather be broken down and driven by the milestones?

The first phase of our project is completed by 18 months. Can most of the proposed budget be used for this initial phase? At that point is there an option to apply for additional funds for the second “option” phase?

Response: The base period is not limited to twelve months. The total duration of a proposed contract should be consistent with the nature and complexity of the offeror’s proposed research. In proposing performance periods for the base and each option, the Offeror should make a reasonable estimate of the time in months that would be needed to complete the activities under the base and each option. The total performance period comprised of the base and any options proposed by an Offeror should not exceed five (5) years. Please refer to Section 3.2.4.1.f, which provides a description of the Milestone Completion applicable to Research Areas 002, 003, and 004.

Question 2: The BAA states that the total amount of funds is $11M from which NIAID expects to make up to 3 awards. For 3 awards, this individual amounts appear to be small given the scope of work envisioned. Will additional resources be made available to support the scope of work? Is cost share expected?

Response: The total cost of up to $11.5 million only applies to the first-year total or base across all contracts for Research Area 003 and 004 that this BAA awards.

Section 3.2.2.3.1 states: NIAID estimates that three or more awards may be issued across Research Area 003 and 004 for a total cost of up to $11.5 for the non-severable base work across all contracts. 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.

Question 3: Limitations in funding for conduct of clinical trials was addressed in Amendment 3, but budgeting considerations for even Phase I trials were not addressed in response. The applicant would indeed design and analyze Phase 1 trials, but would like to make use of resources available from NIAID

HHS-NIH-NIAID-BAA2020-1 Page 7 of 7 through other existing facilities or other subcontractors to NIAID, and thus the costs for clinical trials don’t have to be accounted for in the budget? Similarly, could studies in non-human primates be conducted with subcontractors with which NIAID already has standing contracts and task orders?

Response: The total cost of up to $11.5 million only applies to the first-year total or base across all contracts for Research Area 003 and 004 that this BAA awards. Phase I and 2 are within the scope of this BAA and thus their conduct and associated budgets can be proposed under this BAA as part of the multi-year program.

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

Question 1: Is the total cost of up to $2 million across all contracts annually or total cost of up to $2 million, across all contracts, for the full performance period?

Response: Total cost of up to $2 million across all contracts for the first-year total or base work.

Question 2: Does the prohibition of a culture step and the maximum of one hour only apply to the pathogen detection part of the diagnostic or also for the phenotypic antibiotic susceptibility determination part?

Response: The maximum of one hour applies to the pathogen detection. The phenotypic antibiotic susceptibility determination step may also involve an incubation step but is prohibited from using standard microbiology culture techniques used in clinical laboratories.

Question 3: If we propose a diagnostic for Francisella tularensis, can we assume that NIAID is interested in this particular pathogen primarily from a biodefense preparedness perspective (i.e., the diagnostic will be a countermeasure against F. tularensis being potentially used as a biological weapon)?

Response: The goal of this Research Area is to develop clinical diagnostics to detect naturally occurring F. tularensis infections and may include analysis of other clinical sample types.

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.