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

HHS-NIH-NIAID-BAA2020-1 Page 1 of 8 Amendment Ten (10)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT TEN (10)

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

Ten (10) Issuance: March 26, 2020

Number of Pages: 8

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

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

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Division of Microbiology and Infectious Diseases (DMID)

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 Ten is to:

I) Clarify language applicable only to COVID-19 proposals for Research Areas 003, 004, and 005.

II) Update 3.2.3.2 – Work Plan and add paragraphs j. and k. to include language regarding Technical

Proposal Cost Summary.

III) Update 4.3.2.2 – Section 5: Scientific and Technical Personnel and add paragraph 3 to include language for offerors proposing multiple principal investigators.

IV) 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.

I) In response to the Coronavirus public health emergency, this amendment is to clarify language applicable only to COVID-19 proposals for Research Areas 003, 004, and 005:

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

HHS-NIH-NIAID-BAA2020-1 Page 3 of 8

Sections 3.2.2.2.1, 3.2.2.3.1, and 3.2.2.4.1 – Budget and Award Information – the following is amended for COVID-19 only:

Awards are anticipated to be expedited and made in FY2020.

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

Infectious Diseases

Amendment Three - Section 3.2.2.2.3 – Technical Approach – paragraph 2 is hereby deleted and replaced as follows:

Proposals are not expected to have proof of concept data for COVID-19 (e.g., efficacy data in an animal model for a vaccine candidate or supporting well characterized assays, etc.). However, the offeror should have data demonstrating the success of their proposed strategy, technology and/or platform for another indication. For vaccines, the platform utilized should be well developed with previous clinical experience and a defined and scalable manufacturing process that is suitable for use in a global pandemic preferred.

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

(AMR) Infections and Emerging Infectious Diseases

Amendment Three - Section 3.2.2.3.2. – Technical Objectives – last paragraph is hereby deleted and replaced as follows:

Offerors may propose a lead series/lead small molecules or biologics that have demonstrated at least in vitro efficacy against RNA viruses including coronaviruses with acceptable safety margins, have good understanding of the mechanisms of action, and have developed a scalable synthesis route. Candidate therapeutics under development for other indications that may have efficacy for

COVID-19 are eligible and should summarize work done thus far on related indications. Approved and repurposed drugs will not be supported under this BAA.

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

Diseases – language remains unchanged from Amendment Three.

II) Update 3.2.3.2 – Work Plan to add paragraphs j. and k. for language associated with Technical

Proposal Cost Summary.

j. A Technical Proposal Cost Summary to include: a list of all subcontracts by activity (for example, GMP manufacture, IND-enabling toxicological studies, formulation and fill, etc.) including a budget for each stage of product development proposed for funding (direct costs plus indirect costs).

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k. The technical proposal should include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the Offeror's understanding of the project may be evaluated

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf).

However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs.

III) Update 4.3.2.2 – Section 5: Scientific and Technical Personnel to add paragraph 3 for offerors proposing multiple principal investigators.

3.) Multiple Principal Investigators

The NIH now provides offerors the opportunity to propose a multiple Principal Investigator (PI) model on research and development contracts. The multiple PI model is intended to supplement, and not replace, the traditional single PI model. The NIH chose this RFP as a candidate for the multiple PI model. Ultimately, the decision to submit a proposal using the multiple PI versus single PI is the decision of the investigators and their institutions. The decision should be consistent with and justified by the scientific goals of the project.

It is essential that organizations consider all aspects of this approach before submitting a proposal.

While there are some projects that clearly are appropriate for the multiple PI model, the "fit" of other projects may not be so clear. Offerors should base the selection of either the single PI or multiple PI option on the research proposed, to ensure optimal facilitation of the science. Projects suitable for the multiple PI model could include as few as two PIs who are jointly responsible for the scientific and technical direction of the project. The multiple PI option is based on the proposed project, not on the number of performance sites or the number of participating institutions.

Multiple PIs under research contracts shall use the Subcontract Model. In this approach, offerors submit a single proposal, and a single award is made to the prime contractor. The prime contractor, when appropriate, will award subcontracts to fund the components of the project at the other institutions.

The relationship between the contractor and subcontractors must be designed to support all components of the project. To facilitate communication with the NIH, the offeror must designate a Contact PI at the time of proposal submission. The Contact PI must be employed at the prime contractor's organization. The designation of the Contact PI may rotate on an annual basis.

However, this rotation is restricted to PIs located at the prime contractor's organization. The Contact PI is responsible for: relaying communications between all of the PIs and the NIH, and coordinating progress reports for the project. Being named Contact PI does not confer any special authority for the project.

Leadership Plan: Offerors proposing multiple PIs will need to submit a Leadership Plan as part of the Technical Proposal. The Leadership Plan shall describe the governance and organizational structure of the research project including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The Leadership Plan shall follow the Table of Contents provided below:

I. Rationale Include a discussion of how the project will be enhanced by the multiple PI approach.

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

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II. Identification of all proposed PIs Identify the proposed PIs, their point of contact information and affiliated organizations, and the percentages of time proposed for this project. Identify the Contact PI and plans for rotation of that role, if any.

III. Roles and Responsibilities Identify both the scientific and administrative roles and responsibilities of all named PIs.

IV. Approach to Fiscal and Management Coordination Describe how the project will be performed and monitored from a fiscal and management perspective. Discuss organizational administrative coordination and support.

V. Project Direction and Resource Allocation Address how decisions will be made regarding scientific direction, and, how resources will be allocated and redistributed if needed during performance.

Address plans for shared resources such as IT or other shared data considerations. If joint standard operating procedures will be developed, describe this process.

VI. Communication and Lines of Authority Address communication and lines of authority within and among PIs and within and among organizations.

VII. Data sharing, Intellectual Property, Publication, and other Proprietary Considerations Data sharing plans, intellectual property considerations, publication agreements, and any other proprietary or confidential information sharing should be addressed in this section.

VIII. Conflict Resolution Address how conflicts will be avoided, identified, and resolved.

IX. Other Address any other information relative to the leadership approach to Multiple PI projects.

Offerors submitting single PI proposals do not need to submit a Leadership Plan.

IV) The Government’s responses to questions received regarding this solicitation are as follows:

GENERAL QUESTIONS

Question 1: Regarding the NIH Late Application Policy (Notice Number: NOT-OD-20-082), can you confirm that the policy applies to proposals submitted for BAA: HHS-NIH-NIAID-BAA2020-1?

Response: Notice Number: NOT-OD-20-082 applies to grant applications; it does not apply to this solicitation. Proposal due dates for Research Areas 001, 003, 004, and 005 remain unchanged as specified above.

Question 2: In BAA: HHS-NIH-NIAID-BAA2020-1, there is a requirement for Post-Award and Annual Contract Review Meetings onsite in MD and includes key subcontractor personnel. In the case that key subcontractor personnel were unable to travel, would it be acceptable for these persons to join the meetings remotely (e.g., video or teleconference)?

Response: Yes, subcontractors’ participation in meetings can be in-person, video, or teleconference.

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Question 3: We are working with a consulting firm to develop and finalize our intended proposal submission to HHS-NIH-NIAID-BAA2020-1 Area of Interest No. 4. Our PI intends to utilize the eCPS gateway to submit the proposal, however given the current situation with COVID-19, we are concerned about the potential for connectivity or internet access issues and have requested that our partner be ready to submit the proposal on our behalf as a designee per Amendment 9 to the BAA, “Either the Principal Investigator, designee, or an institutional official can submit the proposal in eCPS. See Section

4.3.2.1.2 – Online Submission of Electronic Proposals (page 61).” Can we rely on a designee from outside its organization to submit the proposal on our behalf, and if so, does the designee need to be specifically noted either in the proposal or to the receiving official in advance?

Response: The NIAID requires proposals to be submitted online via the electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted. It is the responsibility of the Prime to ensure its proposal is submitted in accordance with the proposal submission instructions and by the due date/time stated. An offeror shall use its professional judgement when submitting a proposal via eCPS. An offeror shall provide details of individuals in the Proposal Summary and Data Record (NIH-2043 - Attachment 7) and Offeror’s Points of Contact (Attachment 10).

Question 4: For COVID-19, I have the following questions:

a) I see the Technical volume has a 150-page maximum limitation. Is there a required page minimum?

b) Can I submit a white paper or partial technical proposal?

c) Is a comprehensive Business Proposal required?

Response: a) You are correct, the 150-page limit is a maximum number of pages for the Technical Proposal. There is no minimum page count required for the Technical Proposal.

b) Offers submitted in response to this BAA must present separate 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. Please refer to the proposal instructions presented in Section 4 of the solicitation for further information.

A Technical Proposal must demonstrate the feasibility of its approach and its relevance to the appropriate Research Area and the technical requirements of the BAA. An offeror must submit information sufficient to evaluate their proposals based on the detailed criteria as described in Section 6

– Evaluation Factors for Award. The merit of each technical proposal will be evaluated by a peer review group. Thus, Offerors must demonstrate in their proposals that they have the necessary expertise and capabilities for conducting the proposed research.

As identified in response a) above, Technical proposals are limited to 150 pages, inclusive of CVs;

however, an offeror may choose to submit a proposal with less pages provided the proposal includes adequate information necessary for the evaluation of the candidate product in accordance with Section 6

– Evaluation Factors for Award.

c) Offerors are encouraged to limit the content in its business proposal to only those documents required by the solicitation. A business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, shipping, indirect costs and fee.

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Question 5: I have been trying to determine which of the forms Attachments in Section 7 are required for a Contract Proposal that addresses Area #4. I don’t see text specifically asking for a Technical Proposal Cost Summary for area #4, while I find it explicitly stated that research area #5 does require it.

Can you clarify whether this is required?

Response: The Technical Proposal Cost Summary is required. Section II of this amendment updated the Work Plan in Section 3.2.3.2. of the omnibus BAA to include language for submission of the Technical Proposal Cost Summary

SPECIFIC RESEARCH AREA QUESTIONS

Division of Microbiology and Infectious Diseases (DMID)

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

Question 1: Our project will focus on therapeutic small molecule for treating P. aeruginosa and other MDR pathogens that produce pneumonia and acute respiratory distress syndrome (ARDS), similar to viral infections as in CoVid-9. However, in research area #4 when we looked at category A, B, and C pathogen list (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens), we didn't see P. aeruginosa anywhere. However, we found this severe acute respiratory syndrome associated coronavirus (SARS-CoV), MERS-CoV, and other highly pathogenic human coronaviruses (new in FY14).

Does our product qualify for this solicitation? Can you please elaborate the exact expectation?

Response: Section 3.2.2.3.3, Technical Approach of Amendment Two of the BAA states that antimicrobial therapeutics must demonstrate activity against the effects of one or more of the urgent or serious drug-resistant bacterial threats or urgent fungal threat (Candida auris) listed in the 2019 CDC Antibiotic Resistance Threats Report (https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf). P. aeruginosa and other MDR pathogens are listed on this CDC threat list and are supported by this BAA.

Due to the competitive nature of the solicitation, the Government is unable to provide feedback regarding specific technical approach. An offeror should carefully review the content of the BAA for information regarding the technical objective of each Research Area of this omnibus BAA (Section 3 – Research Areas and Technical Objectives), instructions regarding the proposal submission (Section 4 – Instructions, Conditions, and Notices to Offerors and Section 5 – Special Contract Requirements), and a description of the evaluation and award process (Section 6 – Evaluation Factors for Award); and exercise its professional judgement in compiling its proposal.

Question 2: Is it allowable to have Co-investigators and how many are you allowed to have?

Response: An offeror may propose multiple Principal Investigators (PI). Ultimately, the decision to submit a proposal using multiple PIs is the decision of the investigators and their institutions. The decision should be consistent with and justified by the scientific goals of the project.

Offerors proposing multiple PIs will need to submit a Leadership Plan as part of the Technical Proposal.

Please see section III. of this amendment for further information regarding the Multiple Leadership Plan.

https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

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If you are proposing the co-investigators as key personnel, but not PIs, you do not need to submit a Leadership Plan.

Question 3: Will there be another such solicitation focusing on research area #4 in 2020 or this is the only one for this year?

Response: The NIAID Omnibus BAA is an annual solicitation, and similar Research Area 004 and/or other research area(s) may be added in future years. However, currently there are no additional research areas planned for the 2020 NIAID Omnibus BAA.

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