Amendment 3 - HHS-NIH-NIAID-BAA2024-1.pdf

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2024 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2024-1

Solicitation Amendment (Three) 3

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Room 3D39, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2024-1

Date of Solicitation Issuance: December 13, 2023

Date of Amendment One Issuance February 6, 2024

Number of Pages: Eight Pages

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

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Vaccine Candidates

March 12, 2024

Therapeutic Candidates

In Vitro Diagnostics

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

Please see the Proposal Submission Instructions (Section 4.3.2.1) for more information. For planning purposes, the Government requests potential Offerors to submit a Notice of Intent.

Please see Notice of Intent (Section 4.3.2.1.4) for more information.

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Contracting Office Points of Contact:

Alexandra J. Buck, JD Contracting Officer *Email: NIAID_DMIDOmnibusBAAQuestions@nih.gov

*As a reminder, any correspondences regarding the BAA solicitation, including business and/or technical questions in addition to Notice of Intent letters, must be directed to the Contracting Officer in writing via the following Omnibus BAA email address:

NIAID_DMIDOmnibusBAAQuestions@nih.gov.

Due to the competitive nature of the Broad Agency Announcement, NIAID is unable to offer advice or feedback regarding an offeror’s technical approach.

Acknowledgment of Solicitation Amendment Offerors MUST acknowledge receipt of the amendment by Amendment number (s) and date of the amendment in your proposal. 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 #3

The purpose of Amendment #3 is to provide the NIAID’s response to questions received regarding the solicitation and provide a cut-off date for the submission of questions for this BAA. 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.

GOVERNMENT’S RESPONSES:

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

I. GENERAL QUESTIONS - APPLICABLE TO ALL RESEARCH AREAS:

QUESTION 1: I also saw that the Government requests all potential Offerors intending to propose to this BAA submit an email at no later than January 26, 2024 but that the CO will accept Notice of Intent letters submitted after this date. I am not sure we will be able to submit a notice of intent before Jan 26.

Do you confirm we can submit the Notice of Intent after Jan 26 (and before March 12) if needed?

RESPONSE: Correct, the BAA Solicitation does permit Notice of Intent letters submitted after the date specified in the Solicitation. However, all research areas have the same proposal due date of March, 12, 2024.

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QUESTION 2: We have two potential proposals that can be submitted to this BAA. We would like to solicit DMID/NIAID’s feedback on which project is of higher interest or whether we should submit two BAA proposals.

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding an offeror’s technical approach or advise an offeror which proposal(s) to submit. Please see additional information in the response below.

QUESTION 3: Does a response to the BAA require that the respondent submit a response to all three research areas (vaccine, therapeutics AND in vitro diagnostics) – or is it permissible to submit a technical proposal and response to one only areas (i.e. in vitro diagnostics only) as a stand alone submission.

RESPONSE: Offerors are not required to submit proposals in response to all three Research Areas.

Section 1 of the BAA Solicitation permits offerors to 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.

QUESTION 4: For budgetary purposes, could you please let me know what start date should be used?

RESPONSE: For planning purposes, please utilize May 1, 2025.

QUESTION 5: Is there a cut-off date for the submission of questions regarding this BAA?

RESPONSE: Submit any remaining questions regarding this BAA Announcement by February 20, 2024.

QUESTION 6: Under the subheading 4.3.3.1.6 “Small Business Subcontracting Plan”, if the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan.

a. THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.

So does this mean the above requirement does not apply to a small business like our company? That we need not provide the documentation for subcontracting plan?

RESPONSE: Correct. Small businesses/small business concerns do not have to submit Small Business Subcontracting Plans.

QUESTION/COMMENT 7: NIH recently released changes in the FY2024 NIH Small Business Goals.

Although the Original BAA Solicitation identified the following goals, please see the response below pertaining to the recent changes in the FY2024 NIH Small Business Goals.

Original BAA Solicitation

32% for Small Business; 5% for Small Disadvantaged Business; 5% for Women-Owned Small Business; 3% for HUBZone Small Business; and 3% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.

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RESPONSE: Please see the recent changes in the FY2024 NIH Small Business Goals. Offerors should utilize the updated goals below based on the current percentages.

FY 2024 NIH

Small Business Goals

Small Business (SB)

Small Disadvantaged Business

(SDB)

Women- Owned Small Business

(WOSB)

Service- Disabled Veteran Owned Small Business

(SDVOSB)

Historically Underutilized Business Zone Small Business (HUBZone)

Prime Contracting

30.00% 15.50% 8.83% 3.00% 2.00%

II. SPECIFIC RESEARCH AREA QUESTIONS:

A. RESEARCH AREA 001

QUESTION 1: Does the priming organization need to hold the IP to the vaccine candidate? Or can a partnering organization who does not hold the IP but will provide essential services be the prime?

RESPONSE: Please refer to Section 4.3.3.1.21 - Intellectual Property – of the BAA Solicitation.

“The awardee is solely responsible for the timely acquisition of all appropriate property rights, including intellectual property rights, and all materials needed for the awardee to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any property rights, including intellectual property rights, or any materials needed by the awardee to perform the project. The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).”

QUESTION 2: We would like to be aware about any BAA or RFA announcement that the NIAID releases. Are there any specific email alerts that I could subscribe to obtain these announcements on a timely basis?

RESPONSE: Please refer to www.sam.gov/content/home for other solicitation announcements.

Additionally, please refer to the following link at the NIAID website that allows the public to find contract opportunities: https://www.niaid.nih.gov/grants-contracts/contract-solicitations .

Also, the following link provides a free email subscription service that allow users to receive notification by email. https://www.niaid.nih.gov/global/email-updates

QUESTION 3: We had a few questions about the attachments listed in Section 8, please see below:

3.a - Attachment 2 - Technical Proposal Cost Summary: Do we need to include this attachment in the technical proposal for Research Area 001? We only see this requested under Research Area 003.

RESPONSE: Yes, this attachment should be included in the Technical Proposal. Please refer to the following BAA Sections:

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4.3.1.2 - Separation of Technical and Business Proposals The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal."

Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

The technical proposal must 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. (See Section 8 - Attachment entitled, “TECHNICAL PROPOSAL COST SUMMARY.)

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. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.

3.6.2 – WORK PLAN - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The Work Plan in the Technical Proposal shall also include:

#10 - A Technical Proposal Cost Summary to include: a list of all subcontracts by activity (for example, GMP manufacture, etc.).

PLEASE NOTE, the BUDGET for EACH STAGE of product development proposed for funding (direct costs plus indirect costs) should be included in the BUSINESS PROPOSAL.

3.b - Attachment 3 - Summary of Related Activities: Do we need to include this attachment in the technical or cost proposal? We do not see reference to this above in the instructions for the technical or cost proposal.

RESPONSE: Please include this Attachment with your Technical Proposal.

QUESTION 4: Would a monoclonal antibody administered as a protein that elicits a rapid onset of immunity following a single dose and provides a durable response but is focused a single member of the NIAID Emerging Infectious Diseases/Pathogens list be considered responsive for Research Area 001?

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding an offeror’s technical approach. However, please review all of Section 3.3.1- Research Area 001-Vaccine Candidates.

B. RESEARCH AREA 002

QUESTION 1: After reading the BAA section 3.3.2.3-Additional Requirements (see below, highlighted in yellow), I have a question about the statement: “proposals submitted to this Research Area shall include the following additional criteria and supporting data:” Does that mean that I need to include supporting data in the last 2 points:

In vivo toxicology using a dosing route and regimen consistent with the TPP.

In vivo pharmacokinetics (PK) in a relevant species with dosing route and regimen consistent with the TPP.

RESPONSE: Please read Section 3.3.2.3 “Additional Requirements” for proposal information (shall include the additional requirements in the bulleted items).

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QUESTION 2: We have a therapeutic candidate that is responsive to Research Area 2 Therapeutics for coronavirus where the requirements are 'Coronaviruses, targeting a novel mechanism of action (MOA) different from SARS-CoV-2 approved drugs or with demonstrated pan-coronavirus activity'. However, this candidate is a mAb and it would appear that this BAA do not cover monoclonal antibodies. Can you confirm that this requirement is strictly enforced, and if so is there another NIAID funding opportunity that we can consider instead?

RESPONSE: Please refer to Section 3.3.2.4 of the BAA Solicitation. Any exclusions are strictly enforced. Please refer to sam.gov for other solicitation announcements.

QUESTION 3: In reviewing the BAA 2024-1 requirements, we noticed that development or clinical testing of monoclonal antibodies was not included. Will there be an additional BAA opportunity which includes biologic therapies such as monoclonal antibodies?

RESPONSE: Please refer to www.sam.gov for other solicitation announcements. It is unknown at this time what will or will be excluded in future BAA announcements from NIAID.

QUESTION 4: Before we start, we wanted to double check on the suitability of this data with respect to the “additional criteria and support data” listed on pages 10-11 of the solicitation:

In vitro assessment of absorption, distribution, metabolism, excretion, and toxicity (ADMET).

Preliminary studies performed through a third party independent CRO

Therapeutic efficacy in an animal model of disease must be relevant to the indication identified in the TPP. Efficacy testing must include dosing after challenge. Pulmonary indication has not been studied as yet. Will be part of this application

In vivo toxicology using a dosing route and regimen consistent with the TPP. IV Toxicology performed by third party CRO would need full dosing to be performed once efficacy model is established.· In vivo pharmacokinetics (PK) in a relevant species with dosing route and regimen consistent with the TPP. PK/PD studies performed in rat IV studies. Will require pulmonary route to be performed.

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding an offeror’s technical approach and/or whether to submit a proposal. Please refer to Section 3.3.2. for requirements of Research Area 002.

QUESTION 5: I am the Principal Investigator for a proposal that we are planning to submit in response to the recent BAA solicitation that is supporting the discovery/development of broadly active direct-acting antivirals targeting coronaviruses and/or agents that target SARS-COV-2 with novel mechanisms of action. We have identified a promising series that we believe forms the basis for a strong submission. As the deadline for submission is approaching, there is limited time to schedule and complete key animal efficacy studies that are outlined as a requirement in the solicitation. The problem that we are facing are the longer than anticipated lead times due to the classification of SARS-CoV-2 as a BSL-3 level pathogen.

Basically, there are not that many facilities that are approved and qualified to do this work and there is significant competition for access. We were wondering if it is possible/allowable to submit the majority of the package at the deadline and positive efficacy data prior to peer review?

RESPONSE: Please refer to the sections below in the BAA Solicitation which do not permit an extension for additional data.

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4.3.2.1.1 - Receipt Date

This BAA includes three distinct Research Areas, each with a specified closing date and time, identified below. An Offeror must submit a separate and distinct proposal for each Research Area to which it wishes to propose.

RESEARCH AREA TITLE RECEIPT DATE AND TIME

001 Vaccines Candidates 3:00 PM Eastern Daylight Time 03/12/2024

002 Therapeutic Candidates 3:00 PM Eastern Daylight Time, 03/12/2024

003 In Vitro Diagnostics 3:00PM Eastern Daylight Time, 03/12/2024

4.1.1.2 - Submission, modification, revision, and withdrawal of proposals.

i. Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation.

4.1.1.4 - Offerors may submit modifications to their proposals at any time before the solicitation closing date and time.

C. RESEARCH AREA 003

QUESTION 1: I am writing to request clarification regarding the inclusion of positive blood culture as a specimen type for HHS-NIH-NIAID-BAA2024-1 Research Area 003, item #3 (Phenotypic Antimicrobial Resistance Characterization).

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback regarding an offeror’s technical approach. Please review Section

3.3.3.4 for activities that will not be considered under this research area.

QUESTION 2: In regard to the 2024 NIAID Omnibus Broad Agency Announcement HHS-NIH-NIAID- BAA2024-1, specifically Research Area 003: In Vitro Diagnostics, is there an interest in a state-of-the-art high throughput multiplex serology test, measuring immune responses to hundreds of pathogens from thousands samples simultaneously? We have a near patient testing system that we feel fits the current Broad Agency Announcement.

RESPONSE: Due to the competitive nature of the Broad Agency Announcement (BAA), NIAID is unable to offer advice or feedback on whether to submit a proposal. Please review Section 3.3.3 Research Area 003-In Vitro Diagnostics, to include Section 3.3.3.4 for the list of activities that will be excluded from peer review and will not be considered for award.

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QUESTION 3: In the BAA solicitation, it says that "Developers should present sufficient and convincing proof-of-concept data that the proposed diagnostic method can detect the targeted pathogen analyte (see pathogen list above) preferably from a relevant clinical matrix (e.g., blood, urine, respiratory swab, cerebrospinal fluid, stool, or bronchoalveolar lavage)." Does this mean that companies applying must have feasibility data for all the target(s) that will be part of the panel (including the relevant ones on the list in the solicitation) or is having feasibility data for similar types of targets (i.e., similar sample types, sensitivity, etc.) sufficient to demonstrate the platform capabilities?

RESPONSE: Per Section 3.3.3.2, applicants must have sufficient feasibility research completed for their diagnostic test system, with at least one target being from among the list shown in Section 3.3.3.2.