Amendment 5 - HHS-NIH-NIAID-BAA2024-1.pdf

HHS-NIH-NIAID-BAA2024-1 Page 1 of 4 Amendment Five (5)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2024 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2024-1

Solicitation Amendment (5) Five

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 March 1, 2024

Number of Pages: Four 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.

HHS-NIH-NIAID-BAA2024-1 Page 2 of 4 Amendment Five (5)

Contracting Office Points of Contact:

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

*PLEASE NOTE: The due date for the submission of questions in response to this BAA closed on February 19, 2024. This is the Final Solicitation Amendment addressing questions received through February 19, 2024.

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 #5

The purpose of Amendment #5 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: Does the principal investigator for a clinical trial need to be an employee of the prime contractor? Or can the PI for the clinical trial be a subcontractor?

RESPONSE: The Principal Investigator for the clinical trial does not need to be an employee of the prime contractor.

QUESTION 2: We note that "No NIH funds can be used for research involving a Select Agent or Toxin at a domestic institution without a valid registration certificate," which we and our subcontract (no foreign sites) will not do until we obtain the valid registration number on or around June 2023. We would like to know if the lack of the registration will preclude us from submitting the proposal for the BAA in March?

We also see that we must obtain prior written approval from the Contracting Officer and discuss the experiment with the Contracting Officer's Representative, should we do this prior to the submission of our proposal?

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RESPONSE: Please refer to Sections 4.3.2.6 and 5.45. There is a paragraph applicable to domestic institutions and what is required for the purposes of preparing your proposal. Registration is required before NIH funds can be used for research under any resulting contract awards from the BAA Solicitation. No NIH funds can used for research involving select agents if the final registration certificate is denied under any resulting contract awards. Offerors should NOT contact the CO nor any COR for prior written approval before submitting a proposal.

II. SPECIFIC RESEARCH AREA QUESTIONS:

A. RESEARCH AREA 002

QUESTION 1: There are several places in the BAA where a TPP is referred to. I’m assuming the sponsor creates their own TPP, but if there is one or more specific TPP(s) for Research area 2 categories, would you please direct us to it?

RESPONSE: Please carefully read through Section 3.3.2, Section 3.5, Section 7, and Attachment 16, for the information pertinent to the sponsor derived TPP.

QUESTION 2: Can you please clarify what is meant by '(non-GLP) in vivo toxicology aligned with the TPP' in the lead optimization category Page 9, for research area 2 vs the repeated statement in preclinical category 'Conducting GLP and non-GLP non-clinical studies for toxicology, pharmacology, and immunogenicity (as appropriate)’ page 10? The reason we are asking is it doesn’t make sense to repeat non-GLP toxicology. Is the Lead Optimization statement more directed to general safety?

RESPONSE: Please refer to Section 3.3.2.2 and apply the stage-appropriate studies for pre-clinical development of candidate compound(s).

QUESTION 3: I am wondering if you could clarify the following issue for our proposal to the RFP referenced in the subject line. On page 11, section 3.3.2.4, item #11 of the solicitation, it states that "development of a device" would be excluded from any contract awards; however, would technical testing and selection of commercially available intranasal devices be excluded too? We may use an initial device in Phase 1 study but opt for a different device as we generate data from the clinical studies.

RESPONSE: Please refer to sections 3.3.2.4, 3.6.2, Attachment 16, and Section 4.3.2.3.2 with respect to the language involving devices.

QUESTION 4: Section 3.3.2.2 Technical approach section ' For some pathogens, product efficacy determination under the animal rule is supported'. Is Coronavirus one of those pathogens?

RESPONSE: Please refer to regulatory guidelines, including the FDA Animal Rule (21 CRF 314.600- 650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002), to determine the anticipated approval pathway for your product.

QUESTION 5: Section 4.3.2.3.3 . This section lists the research team educational requirements for protection of human subjects. Does UK GCP training count or do UK team members need to do the American training online?

RESPONSE: Please refer to sections 4.3.2.3.2, 4.3.2.3.3 and 5.5 in the solicitation. Offerors should provide the requested information based on their determination whether their documented training

HHS-NIH-NIAID-BAA2024-1 Page 4 of 4 Amendment Five (5) satisfies the requirements. The information is not a scored evaluated factor and any determination of whether additional training is needed will be made post award if a contract is awarded.

B. Research Area 003

QUESTION 1: Agnostic vs. Targeted Sequencing: This year's BAA mentions both targeted and agnostic approaches. We are developing a technology that offers innovative solutions for both agnostic and target ed sequencing using Next-Generation Sequencing (NGS). We would like to inquire if such an applicati on would be considered favorably or if it falls outside the scope of AOI 003.

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 refer to Section 3.3.3 for information.

QUESTION 2: Portable Sequencer Requirements: Previous BAA announcements for this AOI required sequencing to be performed on an existing, 510k-approved portable sequencer. We would like to clarify if this requirement remains in place for the current BAA. Can we propose using existing portable systems like the Illumina Miniseq and ONT MinION for our proposal, even if they are not currently 510k-approved?

RESPONSE: Please carefully read through all of Section 3.3.3, 3.6, and 3.7; however, there are no requirements for development on 510(k)-cleared instruments.

QUESTION 3: Technology Readiness Level (TRL) for Desktop Automation: Our proposal incorporates desktop automation within a clinical setting. Is there a minimum TRL requirement for the proposed technology in this context?

RESPONSE: Please read through all of Section 3.3.3; however, there is no minimum TRL requirement for Research Area 003 of the BAA.

QUESTION 4: 510k Requirement for Assay/Automation System: If our proposal includes an assay and/or automation system, will obtaining a 510k clearance be a mandatory requirement? We believe our technology holds significant potential in advancing NGS sequencing capabilities and would be grateful for your guidance on these points.

RESPONSE: Please read through all of Sections 3.3.3, 3.6, and 3.7; however, obtaining 510(k) clearance or submission are not requirements for Research Area 003 of the BAA.