Amendment 2 - HHS-NIH-NIAID-BAA2021-1.pdf

HHS-NIH-NIAID-BAA2021-1 Page 1 of 6 Amendment Two (2)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2021 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2021-1

Solicitation Amendment (Two) 2

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-BAA2021-1

Date of Solicitation Issuance: February 23, 2021

Date of Amendment One Issuance April 15, 2021

Number of Pages: Six pages

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

Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE PROPOSALS DUE*

DMID

Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

05/24/2021

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

05/24/2021

Advanced Development of Sequencing- Based Diagnostics for Biothreats and Emerging Infectious Diseases

05/24/2021

*Proposals must be received before 3:00 PM Eastern Time on May 24, 2021.

Contracting Office Points of Contact:

Primary Contact:

Alexandra Buck, Contracting Officer Email: alexandra.buck@nih.gov Phone: 240-669-5174

HHS-NIH-NIAID-BAA2021-1 Page 2 of 6 Amendment Two (2)

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 #2

The purpose of Amendment Two is to 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.

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: If proposing CROs, do they need to be USA domestic?

RESPONSE: All offerors, including foreign entities, not otherwise prohibited by law are eligible to respond to this BAA. 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.

QUESTION 2: Does the offeror need multiple CRO bids/budgets in the proposal or would this be an activity to take place during a negotiation phase?

RESPONSE: As referenced in the Solicitation, offerors proposing subcontracts and/or consultants to perform portions of the proposed work should clearly identify the specific tasks for which they plan to utilize subcontractors and/or consultants, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors and/or consultants, and the expected advantages of such an approach. Processes for subcontractor and consultant identification, selection, management and evaluation should be described in the proposal. An offeror’s initial proposal should contain the offeror’s best terms from a price and technical standpoint.

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QUESTION 3: Does project background information go in section 3 (Statement of Work / product development plan or work Plan) or section 4 (technical discussion)?

RESPONSE: Background information that provides a context for the technology proposed should be included, as needed, where the offeror feels is most appropriate.

QUESTION 4: The link provided in BAA to Attachment 7 - "Proposal Summary and Data Record (NIH 2043)" is a form dated June 1982 - is this the correct version of the form for offerors to use?

RESPONSE: Yes, this is the correct version.

QUESTION 5: Attachment 14 - "PHS Human Subjects and Clinical Trials Information Form" - Is this the same as clinicaltrial.gov registration? If we do not plan on conducting clinical trials as part of this proposal, do we need to still complete this form?

RESPONSE: Please refer to Section 4.3.2.1.2.c. All Offerors must complete: “PHS Human Subjects and Clinical Trials Information Form” available in Section 7 “Attachments”. This form must be submitted as a separate document in eCPS for all proposal submissions in addition to the Technical and Business Proposals.

QUESTION 6: In reference to Page 55, is the Human Subject Section part of the page count for the Technical Proposal?

RESPONSE: Yes, it is included in the 150 page count of the technical proposal.

QUESTION 7: Is there a portal we have to use for submission of proposals?

RESPONSE: Yes, please refer to section 4.3.2.1.2 – Online Submission of Electronic Proposals.

QUESTION 8: Is there any guidance documents or templates?

RESPONSE: Offerors should carefully review the content of the BAA for all guidance and instructions and exercise its professional judgement when compiling its proposal. Templates applicable to the BAA ,which may be required in the offeror’s proposal, are located in Section 7 of the BAA.

QUESTION 9: Is there a pro-forma document for generating a Target Product Profile?

RESPONSE: There is no pro-forma document for a Target Product Profile. Review section 3.2.2.4.I and 3.3.1.b for guidance.

QUESTION 10: In our work in other programs we have seen extended delays in delivery on key supplies and it has impacted the schedules. Will we need to forecast those same timelines here or is there the potential for priority rated ordering with an award in this area?

RESPONSE: The NIAID has no control over the delivery schedule for any supplies to be purchased by potential awardees. 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

HHS-NIH-NIAID-BAA2021-1 Page 4 of 6 Amendment Two (2) performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.

II. SPECIFIC RESEARCH AREA QUESTIONS

1) RESEARCH AREA 001:

QUESTION 1: Are the following two pathogens in scope of the BAA:

1A) A vaccine against Borrelia species, causing Lyme’s disease (Vaccines for Pandemic Preparedness and Emerging Infectious Diseases). Here, tick borne viruses are specifically mentioned; however, would a vaccine against a tick borne bacterial disease be in scope?

RESPONSE: Yes, it is in scope of the BAA.

1B) A vaccine against Neisseria gonorrhoeae, causing gonorrhea (Vaccines for Anti-Microbial Resistant (AMR) Organisms).

RESPONSE: Yes, it is in scope of the BAA.

2) RESEARCH AREA 002:

QUESTION 1: On Page 11, Section 3.2.2.3 states "…therapeutic candidates that target high-priority pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern are eligible…" while page 13, Section 3.2.2.5, states that contract awards under this Research Area will not support "development of candidates/products or lead series that have not demonstrated therapeutic activity in a relevant animal model of disease OR have not demonstrated stage appropriate pharmacokinetics".

RESPONSE: Section 3.2.2.3 specifies that proposals are eligible under this solicitation for therapeutics with a limited spectrum of activity provided that they target high-priority pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern. Section 3.2.2.5 specifies that for a contract to be awarded the development candidate must have demonstrated therapeutic activity in a relevant animal model of disease and stage appropriate pharmacokinetics.

QUESTION 2: Our proposal to this BAA includes FDA required in-vitro and in-vivo anti-viral studies needed for an IND application. Are there any additional requirements for Research Area 002?

REPONSE: Section 3.2.2.4 specifies that the offeror of the proposed therapeutic lead series, lead or product candidate must provide the chemical structure and if appropriate, relevant structure activity relationships to support lead optimization. The proposed therapeutic lead series/lead/product candidate must demonstrate a feasible synthetic/manufacturing process, appropriate in-vitro and in-vivo activity, efficacy, pharmacokinetics and toxicology that must be reflected in the draft Target Product Profile.

QUESTION 3: Is a draft "Target Product Profile (TPP)" supposed to be included in this BAA proposal submission?

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RESPONSE: Yes.

QUESTION 4: Does the Broad Agency Announcement apply only to therapeutics for direct human treatment?

RESPONSE: The goal of the DMID Omnibus BAA is to advance vaccines, therapeutics and diagnostics which could be deployed against biodefense and/or emerging pathogens to protect human health and well-being, i.e. vaccines, therapeutics and diagnostics for human use.

QUESTION 5: Is a clinical trial required for Research Area 002?

RESPONSE: Review section 3.2.2.2, “Research Area 002 will support lead optimization, pre-clinical (IND enabling studies) and clinical trials that include Phase 1 and Phase 2 studies or confirmatory trials no greater than 120 subjects. The scope of support differs depending on the stage of the project being proposed.”

QUESTION 6: We have a novel series of antibacterials based on a natural product with demonstrated in vivo activity against a Category A pathogen and in vitro potency against another Category A and a CDC AR high threat organism. The putative mechanism of action is novel but not completely elucidated. Is this considered a lead optimization stage candidate for this BAA?

RESPONSE: Review section 3.2.2.2 for details describing the development phases in-scope of Research Area 002.

QUESTION 7: Can we apply with a specific proposal for SARS-COV-2 for Research Area 2?

RESPONSE: Review section 3.2.2.3.2.b.iv. of the BAA.

QUESTION 8: Does the NIAID consider a de novo designed minibinder anti-viral protein targeting SARS-CoV-2 Spike to be the same as a "monoclonal antibody"?

RESPONSE: For the purposes of this solicitation, minibinder proteins are not considered monoclonal antibodies. Refer to section 3.2.2.2 for details describing the development phases in-scope of Research Area 002.

QUESTION 9: Could you define the word "licensed products" in page 13 in the solicitation (3.2.2.5)?

RESPONSE: For the purposes of this solicitation, licensed products in section 3.2.2.5 includes drugs approved for marketing in the United States under section 505 of the FD&C Act and biologics licensed under section 351 of the PHS Act.”

3) RESEARCH AREA 003:

QUESTION 1: I am just looking into some guidance into what in scope projects are allowed to propose. If you cannot propose hardware development, it seems to me that software development should be allowed, but I would like some clarification. Question 1 of Research Area 003 is: “Can you please clarify established commercial platforms? Does this include platforms that will be commercially available before the completion of the period of performance if not today?” The response is where my confusion is, specifically the bolded text:

HHS-NIH-NIAID-BAA2021-1 Page 6 of 6 Amendment Two (2) o “The sequencing-based diagnostic assay solutions should be developed on platforms that are already in use commercially, or will be available commercially co-incident with the assay. The goal is to reduce overall test system development time caused by delays in hardware and software design and development. In this solicitation, no funding will be available for hardware or software development. In the original solicitation, on Page 15 under activities IN SCOPE for Research Area 003 there is software development listed:

Software development, including database improvement for faster and/or more comprehensive analysis patient sample data.”

RESPONSE: The previous response is hereby deleted and replaced with the following: “The sequencing-based diagnostic assay solutions should be developed on platforms that are already in use commercially, or will be available commercially co-incident with the assay. The goal is to reduce overall test system development time caused by delays in hardware design and development. In this solicitation, no funding will be available for hardware development.”