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

HHS-NIH-NIAID-BAA2023-1

Page 1 of 5 Amendment Six (6)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Six (6)

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 Six Issuance February 27, 2023

Number of Pages: Five (5)

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 SIX (6)

The purpose of Amendment Six (6) is to:

I. 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. GOVERNMENT’S RESPONSES TO QUESTIONS RECEIVED REGARDING THIS

SOLICATION ARE AS FOLLOWS:

A. General Questions applicable to all Research Areas:

Question 1: We would like to know how far back we can go in getting cost-reimbursements if some of the work gets completed before the grant begins (it looks like in May 2024)

Response: Contracts resulting from this BAA shall not reimburse costs incurred in connection with work performed outside the contract’s period of performance. Costs incurred before the contract’s effective date or after its completion date are unallowable and cannot be charged to the contract.

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

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

Page 3 of 5 Amendment Six (6)

Question 2: We are considering a subcontractor for some animal studies that is a global company and where the proposed work may be performed outside the US. Are there any considerations for foreign subcontractors I should be aware of for this application?

Response: An offeror may propose a foreign subcontractor, not otherwise prohibited by law, to perform animal studies. If successful, clearance by the State Department will be obtained prior to awarding a foreign contract, a foreign subcontract, or a domestic contract with a foreign component. Additionally, a written animal welfare assurance approval from the NIH Office of

Laboratory Animal Welfare (OLAW) is required prior to the initiation of an animal study conducted domestically or globally. See Sections 4.3.2.4, 4.3.2.5, 5.30, 5.31, and 6.6 of the BAA.

Question 3: Does NIH have a recommended or preferred vendor of nonhuman primates for use in proposed nonclinical studies?

Response: The Government cannot make specific recommendations regarding potential subcontractors or vendors. All animal vendors and studies are required to follow NIH policy and

PHS regulations. See section 4.3.2.4 - 4.3.2.5 of the BAA.

Question 4: I missed the February 21, 2023 deadline to submit the Notice of Intent. Can I still submit it?

Response: For planning purposes, the Government requests potential offerors to submit a Notice of Intent. Although notification was requested by February 21, 2023, a Notice of Intent may be submitted any time before the proposal due date of the respective Research Area. See Section

4.3.2.1.4 of the BAA.

Question 5: Are Phase 1 and/or Phase 2 clinical trials required for Research Areas 002 and

003?

Response: Clinical trials are not required for proposals that include lead optimization; however, Phase 1 and/or Phase 2 clinical trials are required for proposals that do not include lead optimization. See Section 3.3.2.2 of the BAA.

B. RESEARCH AREA 001

Question 1: Alphaviruses are specifically listed as a topic of interest, would Western Equine

Encephalitis Virus/Venezuelan Equine Encephalitis Virus/Eastern Equine Encephalitis Virus

(WEEV/VEEV/EEEV) targets be responsive to the AOI as high priority pathogens under

Alphaviruses?

Response: Yes, these viruses are examples of alphaviruses, which is included in the list of pathogens. See Section 3.3.1.1 - Technical Objectives, 3rd bullet of the BAA.

Question 2: Lassa virus is not listed but other viral hemorrhagic fever pathogens are, would

Lassa virus vaccines be responsive to this AOI?

Response: No, arenaviruses are not responsive.

Question 3: Can offerors leverage existing lead vaccine programs in a separate area (SARS-

CoV-2, preclinical immunogenicity/efficacy, CMC, toxicology, clinical Phase 1,2,3 data) to

Page 4 of 5 Amendment Six (6) sufficiently address the technical approach requirement of "Preliminary data with clinically relevant vaccine candidate has demonstrated proof-of-concept immunogenicity in relevant animal model(s)"?

Response: Preliminary proof of concept immunogenicity data must be included for the same lead vaccine candidate (same pathogen) that is being proposed for the BAA proposal/submission.

Question 4: Is a clinical program (e.g., includes clinical trial plans) a mandatory element for all applications?

Response: Yes, Clinical Development Plan and clinical activities to be undertaken should be included. See Section 3.3.1.2. of the BAA.

C. RESEARCH AREA 002

Question 1: Is developing a rapid diagnostic/treatment platform to enhance the accessibility of phage therapy for AMR infections in the scope of this grant opportunity (especially research area

002)?

Response: Please understand that this solicitation will result in the award of a contract, not a grant. A contract awarded in Research Area 002 can support development of a biological product and non-traditional approaches are encouraged (see Section 3.3.2.1 paragraphs 3 and

4). A contract awarded in Research Area 002 cannot support diagnostic development, which is the focus of Research Area 004. You may submit proposals in multiple Research Areas; however, each proposal should stand alone and fully comply with the requirements of the Research Area to which it is submitted. Proposals in different Research Areas will be peer reviewed separately, and independently of each other, even if related by a common platform technology. See Section 1 of the BAA.

Question 2: Does NIAID regard antitoxin activity in the MNA (mouse neutralization assay) as evidence of therapeutic activity?

Response: No. In the standard mouse neutralization assay animals are treated with antitoxin before intoxication. An antitoxin therapeutic would be administered after symptoms are clinically observable. See Section 3.3.2.1 “Important notice to Offerors” of the BAA.

Question 3: In regards to Attachment 16, would a product that meets all but one of the requirements (e.g. lacks in vivo PK data for the molecule) still be considered for award?

Response: Proposals submitted to Research Area 002 shall include in vivo pharmacokinetics

(PK) in a relevant species with dosing route and regimen consistent with the Target Product

Profile (TPP). See Section 3.3.2.3 Item 2 bullet 8 of the BAA.

Please note that Attachment 16 is provided as a checklist only to aid offerors in determining if the

Technical Proposal meets Research Area 002 requirements and exclusions. 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), instructions regarding the proposal submission

(Section 4) and a description of the evaluation and award process (Section 6); and exercise its professional judgement in compiling its proposal.

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D. RESEARCH AREA 004

Question 1: Are offerors expected to submit proposals that encompass all three objectives of

Research Area 004, or is it acceptable to only address one objective?

Response: It is acceptable to address only one objective in a single proposal.

Question 2: For the 3.3.4.1 objective to improve the overall performance of nucleic acid sequencing solutions on portable commercial sequencing platforms, do all the bulleted development activities that are listed as “in scope” in the BAA need to be addressed, or are those only a selection of examples?

Response: The bulleted items listed as In Scope in Section 3.3.4.1 are examples of research areas that may be addressed in a proposal. They are neither individual nor a sum of requirements for that objective.

Question 3: Would a proposal to detect viral nucleic acid analytes be considered if the diagnostic platform does not utilize portable next-generation sequencing (objective 1)?

Response: Proposals that offer to develop nucleic acid detection via, for example, thermal cycling or isothermal target amplification will not be considered. Proposals that offer to advance current nucleic acid sequencing methodologies to improve speed, accuracy, simplicity, and cost will be considered. See Section 3.3.4.1, item #1. The primary goal in Objective #1 is to “improve overall performance of nucleic acid sequencing.” This includes improvements in cost-effectiveness, sample prep, time to result, throughput limitations, and sequencing accuracy. The secondary goal is “targeted and agnostic detection and identification of microbial pathogens.”

This includes viral nucleic acid analytes from viruses in the published list in Section 3.3.4.2, pp.

17-18.

Question 4: Would it be considered within the scope of Research Area 004 to propose clinical trials for a 510(k) submission and/or development of a multiplex device that targets SARS-CoV-

2, influenza, and RSV?

Response: See Section 3.3.4.2, “The proposed program must (be)…working in early- (planning and design) through late-stage (design verification) development for a diagnostic system.”

Submissions that propose a program in late-stage research or early development that continues up to and including design verification would be considered. Submissions that include final clinical validation and FDA submission for 510(k) clearance only are out of scope and will not be considered. Submissions that propose a multiplex detection system for SARS-CoV-2, which is on the list of required pathogens for targeting, along with other respiratory virus targets, would be considered.