HHS-NIH-NIAID-BAA2023-1 - Amendment Four.pdf

HHS-NIH-NIAID-BAA2023-1

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Four (4)

Issuing Office: 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-BAA2023-1

Date of Solicitation Issuance: January 11, 2023

Date of Amendment Four Issuance February 14, 2023

Number of Pages: Seven (7)

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Development of Vaccine Candidates for

Biodefense and Emerging Infectious

Diseases

April 11, 2023

Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant

(AMR) Infections and Emerging

Infectious Diseases

The Antiviral Program for Pandemics

(APP): Development of Antivirals for

Specific RNA Viral Families of

Pandemic Potential

March 13, 2023

Development of In Vitro Diagnostics for

Biodefense, Antimicrobial Resistant

Infections (AMR), and Emerging

Infectious Diseases

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

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Contracting Office Points of Contact:

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

Secondary Contact:

Ebony Taylor, Contract Specialist

Email: ebony.taylor@nih.gov

Phone: 240-292-0668

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 AMENDMENT FOUR (4)

The purpose of Amendment Four (4) is to:

I. Revise Section 4.3.3.1.4 to reflect the most current version of FAR Clause 52.215-20.

II. Provide the NIAID’s response 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.

Please note, in the questions/responses below, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

I. REVISIONS TO HHS-NIH-NIAID-BAA2023-1 (highlighted in red):

4.3.3.1.4 – Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (Nov 2021)

II. GOVERNMENT’S RESPONSES TO QUESTIONS RECEIVED REGARDING THIS

SOLICATION ARE AS FOLLOWS:

A. General Questions applicable to all Research Areas:

Question 1: Is certified cost pricing data required to be submitted alongside the proposal? I note the following from the solicitation that I am unable to disentangle:

Page 75- Section 4.3.3.1.2 states certified cost or pricing data is not required and the info being requested is to support price reasonableness/cost realism, and not required to be certified IAW

FAR 15.406-2. but then Page 75- Section 4.3.3.1.3 states that options must be submitted with certified cost or price data.

mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov

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Response: Certified Cost or Pricing Data is required unless there is an exception granted by the

Contracting Officer. See Section 4.3.3.1.4 (pages 78-79) of the BAA for details of exceptions.

Question 2: The solicitation says that an award of up to $12.8M will be given. Is that the total amount budgeted within NIAID for the duration of the 5-year award or annually? So, we, as offerors, cannot propose budget that exceeds the above amount?

Response: The NIAID estimates a budget of up to $12.8 million to be divided among the non-severable Base periods of all contract awards for Research Areas 001, 002, and 004, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. The total duration of the Base Period should be consistent with the nature and complexity of the offeror’s proposed research and may vary depending on the scope of the project and technical objectives. See Section 3.2 (page 6) of the BAA.

For “non-severable” definition, please see response to Question 1a. under Research Area 002 of

Amendment Three.

Question 3a: Can the offeror be the sole unit to compete the objectives, that is, with no subcontractors at all?

Response: An offeror is not required to propose a subcontractor(s) if it can perform all the work proposed in-house.

The term “subcontract” means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract.”

See Section 4.3.3.1.6 (page 80) of the BAA.

Question 3b: If subcontractors are involved, what is the limit of subcontractors if any?

Response: An offeror shall exercise its professional judgement in determining its technical approach including whether to subcontract and the number of subcontractors needed to accomplish the tasks of the SOW. Regarding subcontractor limitations, please refer to the hyperlink in Section 5.49 of the BAA (pg. 116) which contains the General Clauses for a Cost-

Reimbursement Research and Development Contract. Included in the list of clauses is FAR

52.215-23 – Limitations on Pass-Through Charges (over the simplified acquisition threshold).

Question 4: Is there a page limit for the business proposal?

Response: There is no page limit for the Business Proposal; however, offerors are encouraged to limit its content to only those documents required by this solicitation, and necessary to provide adequate support for the proposed costs. See Section 4.3.2.1.3 (page 44) of the BAA.

Question 5: Can you please confirm that the 2023 NIAD Omnibus Contract Solicitation will not support development of monoclonal antibody-based therapeutics in any of the 4 areas of interest?

Response:

Research Area 001 will NOT support monoclonal antibody approaches (Section 3.3.1.3, items 3, 6)

Research Area 002 will support monoclonal antibody approaches (Section 3.3.2.1 par. 3)

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Research Area 003 will NOT support monoclonal antibody approaches (Section 3.3.3.4 item 13)

Research Area 004 will NOT support monoclonal antibody-based therapeutics (Section 3.3.4.1, items 1-3)

Question 6: Do we need to submit a Business Proposal?

Response: Yes, an offeror must submit a Business Proposal; otherwise, the offeror will not be considered further for award. See Section 4.3 of the BAA.

Question 7: Per the BAA, our deadline is April 11, 2023 at 3 pm Eastern. When I look at the eCPS submission portal, I see a closing date of March 13, 2023. I want to ensure we will truly have until April 11th to submit our proposal through eCPS. Do you mind confirming this date for me?

Response: Currently, SAM.Gov has a proposal due date of March 13, 2023, 3:00pm ET for

Research Area 003 only. An Amendment to change the proposal due date to April 11, 2023, 3:00pm ET for Research Areas 001, 002, and 004 will occur in Sam.Gov prior to the proposal due date of Research Area 003. In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.

B. RESEARCH AREA 001

Question 1: Will the BAA support early-stage vector development-type proposal or is it directed towards supporting the translational pathway of an established/validated vaccine agent? We are exploring vaccination via the intranasal route employing adenovirus vectors. Based on their utility in this context we now wish to enhance their potency via modifications of vector tropism that augment its ability to infect target cells in the nasal milieu. So, we would employ BAA support the proposed vector engineering and to validate the vaccine gains in animal model systems.

Response: The BAA does not support early-stage vector development. As illustrated in Section

3.3.1.2 Technical Approach, the focus is on the advancement of a promising lead vaccine candidate that has immunogenicity data on that lead candidate. Implicit in this is that the antigenic insert, vector, delivery route and adjuvant have been selected and there is immunogenicity data to support that selection. An offeror must propose development of that lead in its proposal for this BAA. Nonetheless, NIAID may consider minor modifications/optimization of the lead candidate if the data generated post-award supports it.

Below is the criteria for definition of a lead vaccine candidate. See Section 3.3.1.2. of the BAA.

Research Area 001 focuses on the advancement of a promising lead vaccine candidate from pre-clinical testing through evaluation in a Phase 1 or Phase 2 clinical trial. A lead vaccine candidate is defined by the following criteria:

1. Antigen, adjuvant (if applicable), and delivery route have been selected and are clinically relevant. Preliminary data with clinically relevant vaccine candidate has demonstrated proof-of-concept immunogenicity in relevant animal model(s)

2. Prefer, but do not require, evidence of proof-of-concept efficacy data in a relevant animal model

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3. Platform has been defined and is appropriate to support Phase 1 and/or 2 clinical trials.

4. Prefer, but do not require, a defined manufacturing process

5. Prefer, but do not require, characterization of the lead candidate using well-characterized, quality-controlled assays including potency assay(s)

Question 2: We noticed a change in the Research Areas for this 2023 BAA, in which development of vaccine candidates for bacterial emerging infectious disease is no longer included. Has the focus for NIAID shifted to vaccine candidate for viral pathogen only, or should we anticipate other funding opportunities this year that would support vaccine candidates for bacterial pathogens?

Response: For the 2023 BAA, under Research area 001, vaccines against bacterial pathogens are not supported. Please see Section 3.3.1.3 - Contracts awarded under this Research Area will

NOT support the following activities: proposals containing any of these activities will be excluded from peer review and will not be considered further for award: bullet number

5: vaccines against bacterial pathogens.

The Government cannot comment whether future requirements will include vaccine candidates for bacterial pathogens. The onus is on the offeror to check the Government-wide point of entry, also known as SAM.Gov, and other NIH funding announcements for funding opportunities.

C. RESEARCH AREA 002

Question 1: If we wanted to only characterize the in vitro MIC efficacy of a pre-IND chemical entity, would this be considered in scope with one of the following?

Lead Optimization:

• Selecting a preclinical candidate and initiating IND-enabling studies

Pre-Clinical (IND Enabling) Studies:

• Conducting GLP and non-GLP non-clinical studies for toxicology, pharmacology, and immunogenicity (as appropriate); or

• Developing in-process assays and analytical methods for product characterization and release, including assessments of potency, purity, identity, strength, sterility, and quality as appropriate.

Response: No. If in vitro MIC characterization is the only proposed work, the program is pre-lead optimization. Lead Optimization is the earliest development stage supported by contracts awarded under this solicitation. See Section 3.3.2.2 of the BAA.

Question 2: Would the NAID support the development of a microbiome therapeutic given the statement 3.3.2.4. Just to emphasize we are not a probiotic or prebiotic; however, we do restructure the gastrointestinal microbiome with our therapeutics, specifically pathogenic organisms.

Response: Therapeutic approaches as defined in Section 3.3.2.1 to the pathogenic bacteria included in RA 002 are allowed, but do not extend to products that depend on modification of commensal organisms to exert a therapeutic effect. See Section 3.3.2.4 item 10 of the BAA.

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Question 3: Can you please advise as to whether C. difficile infection is of interest to NIAID under this BAA, and if so, would treating post standard antibiotic treatment be considered “post exposure prophylactic”, rendering said intervention non-responsive?

Response: C. difficile is on the Urgent Threat list in the 2019 CDC Antibiotic Resistance Threats report and, therefore, is of interest for this solicitation. The proposed approach should demonstrate therapeutic effect as defined in Section 3.3.2.1 regardless of when in the course of the disease the product is proposed to be administered.

Question 4: I am looking for feedback on whether bacteriophages, which can be anti-AMR but as a biologic do not confirm to many of the standard approaches listed in the call, are specifically excluded or more generally not desired under this announcement.

Response: A bacteriophage approach would be allowed in RA 002.

Question 5: Number 7 of excluded research activities states ‘development of a product that functions as a topical antiseptic’. Our regulatory advice department confirmed that our compound is an antimicrobial product currently used as a topical treatment, the compound is not a topical antiseptic. However, due to slight variations in definitions between Europe and the USA, we were advised to check with you directly before making a full application.

Response: An approach including topical administration of a therapeutic product as defined in

Section 3.3.2.1 would be allowed in RA 002.

D. RESEARCH AREA 003

Question 1: As per NOT-AI-23-025 (area 3) anti-viral program, this program is targeted what stage of drug development? Early or late stages of drug development?

Response: A proposal may include Lead Optimization through IND submission, or it may include

Preclinical development of a candidate through early Phase 2 clinical trials. See the revised

Section 3.3.3.2 in Amendment Three (3) issued on Sam.Gov.

E. RESEARCH AREA 004

Question 1: Under Research Area 004, ““Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases”, would a proposal for diagnostic development be responsive if it addresses viral pathogens shown on the list of agents under section 3.3.4.2?

Response: Submissions must address at least one of the pathogens listed in Section 3.3.4.2 (pp.

17-18) in order to be considered responsive. This list includes several viral pathogens.

Question 2: Under Research Area 004, would proposals that pursue diagnostic development outside of the three specific objective areas described under 3.3.4.1, namely “Next-Generation

Nucleic Acid Sequencing on Portable Systems”, “Protein Detection” and “Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization”, be considered responsive? Our approach does not involve either the “next-gen” sequencing and protein detection of analyte detection.

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Response: Proposals that pursue in vitro diagnostics (IVD) development outside of the three objective areas will be considered unacceptable and will not be considered further for award.

But submissions that pursue IVD product development to detect analytes other than proteins and nucleic acids is in scope. See Section 3.3.4.1 item 2, last bullet: “Target antigens other than proteins will be considered in scope”

Question 3: Is NIAID able to provide more detail on what is meant by:

a. Diagnostic prototype designed for either low-throughput use in near-patient settings or for moderate throughput in hospitals? What is mean by low-throughput and moderate throughput in this context?

b. A portable platform?

c. Commercial sequencing platforms - is a prototype under development that will be commercially available within the time frame of this grant acceptable?

Response: a) Low-throughput in a near-patient setting would have a capacity for concurrent processing of up to 10 patient samples during a single run. Moderate throughput should be high enough for an output of 50-500 patient results per work shift.

b) A portable platform may be described as a size and weight that allows an average laboratorian to transport by hand the device from one location to another via a suitcase or backpack. An offeror shall use its professional judgement to describe and justify the portability of its proposed device.

c) Proposed product development on a platform that will not be commercially available at the start of the contract is out of scope (Section 3.3.4.1, item 1, page 15).

Please understand that this solicitation will result in the award of a contract, not a grant.