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

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

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2021 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2021-1

Solicitation Amendment (One) 1

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 March 17, 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

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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 #1

The purpose of Amendment One is to:

1) Provide the NIAID’s response to questions received regarding the solicitation; and

2) Provide a cut-off date of May 10, 2021 for questions from potential offerors.

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: Uniform Cost Assumptions, item b says ‘cost will not be allowed for the purchase of any equipment…’ I would like confirmation please that even with a COA request we will not be permitted to use the award funds to purchase any equipment? I need to make sure I fully understand what is and is not permitted before I meet with the PI again. I have not seen this in the other awards we have received from NIH and NIAID so I just want to make sure I am not misunderstanding the language.

RESPONSE: Confirmed. In accordance with 3.3.5.b. of the Broad Agency Announcement, “Cost will NOT be allowed for the purchase of any equipment, hardware, or software under this contract.”

QUESTION 2: On page 6, in 3.2.1.1 – Budget and Award Information, the BAA mentions the total performance period will be comprised, as usual, of the base period and options. I was hoping you could tell me if the base period for this proposal will be one or two years in length? We have had different base periods for several of our awards. While most base periods have been for 12 months we have had one span 2 years and yet another base period covered 3 years. For budgeting purposes I will need to be clear on the amount of time we are covering in our base period.

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RESPONSE: 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 performance period comprised of the base and any options proposed by an Offeror shall not exceed five (5) years.

QUESTION 3: Who is eligible to submit a proposal? Are academic groups or academic/industry collaborations able to apply? Are you targeting start-up companies, small businesses, or established large companies?

RESPONSE: This BAA is being competed using full and open competition. All responsible offerors not otherwise prohibited by law are eligible to submit a proposal in response to this BAA Solicitation.

QUESTION 4: Is there a due date for the submission of business or technical questions in response to the solicitation?

RESPONSE: Monday May 10th, 2021 is the last day to submit any questions regarding the BAA Solicitation. Offerors are encouraged to submit their questions timely.

II. GENERAL QUESTIONS - APPLICABLE TO RESEARCH AREAS 001 & 002

QUESTION 1: Section 3.2.2.1 states "NIAID estimates a total FY22 budget of up to $11 million for the non-severable base work (direct and indirect costs combined) across all contracts in Research Areas 001 and 002, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds." We're not certain how to interpret that. Does it mean that there is up to $11M for each award (subject to technical merit, total funds available, and the number of awards), or does it mean that there is up to $11M to be divided between all awards (subject to technical merit)?

RESPONSE: To clarify, NIAID estimates a budget of up to $11 million for the non-severable base period to be divided between all contract awards for Research Areas 001 & 002, depending on the number of technically meritorious proposals, importance to agency programs, and availability of funds. As stated in 3.2.1.1 & 3.2.2.1, NIAID estimates that three (3) or more awards may be issued across RA 001 and 002.

QUESTION 2: Section 3.3.3. of the BAA states “ Upon completion of protocol development, DMID will determine if the offeror will hold the IND and conduct the clinical trial, using the form “Request to Sponsor an IND/IDE for a DMID-Funded Clinical Trial. The form will be included as an attachment to the contract award.” Are offerors able to request a copy of the attachment?

RESPONSE: A copy of the form has been added as an attachment to this Amendment.

QUESTION 3: In examining the Sample Statement of Work for Research Areas 001 and 002 (on page 53), item A. under TECHNICAL REQUIREMENTS lists a Product Development Plan. Are we to interpret these guidelines to mean that we must submit items 4-8 (covering manufacturing, HHS-NIH-NIAID-BAA2021-1 Page 4 of 6 Amendment One (1) clinical trial protocol, process development and cGMP manufacturing) at the time of our proposal submission?

RESPONSE: Please refer to Section 4.3.2.2 - Section 3 - SOW Format (page 52) - “NOTE TO OFFEROR: Each offeror shall provide detailed specifications of the requirement utilizing the following sample outline of tasks and subtasks. Any tasks or subtasks that are not applicable to your proposed effort should be deleted. Any tasks or subtasks specific to your proposed effort not addressed below shall be added.”

III. SPECIFIC RESEARCH AREA QUESTIONS

1) RESEARCH AREA 001:

QUESTION 1: For Research Area 001, do NIAID’s areas of interest for vaccines include tick-borne bacterial disease, especially Borrelia burgdorferi , the primary causative agent of Lyme disease?

RESPONSE: Borrelia burgdorferi is eligible for consideration under Research Area 001.

QUESTION 2: Whether a vaccine candidate to prevent coccidioidomycosis is within the scope of the BAA Research Area 1?

RESPONSE: Coccidioidmycosis is eligible for consideration under Research Area 001.

2) RESEARCH AREA 002:

QUESTION 1: I have been researching the fungal infection Mucormycosis for almost two decades through NIAID funding. Mucormycosis has been listed on the NIAID website as an emerging disease since 2014, but it is not necessarily listed under the A,B,C category organisms.

RESPONSE: Mucormycosis is an emerging infectious disease pathogen and is eligible for consideration under Research Area 002.

QUESTION 2: Pertaining to the recently announced BAA referenced above, I would value your input on whether Research Area 002 could encompass an oral therapy for complicated UTI including ESBLs and CRE.

RESPONSE: Proposals are encouraged for the development of broad-spectrum therapeutics as well as limited spectrum therapeutic candidates that target high-priority pathogens for which no standard clinical treatment exist or for which drug resistance poses a significant public health concern.

QUESTION 3: Does Research Area 002 include host-targeted therapeutics, or is it aimed solely at antimicrobials, antivirals, and anti-toxin therapies?

RESPONSE: Please refer to Section 3.2.2.2 – Technical Objectives: “Proposals on non-traditional therapeutics and anti-toxins are encouraged, provided they have demonstrated therapeutic activity when used alone or in combination with an existing licensed product.

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QUESTION 4: For which of the studies would we be required to obtain our own FWA# prior to submission of the proposal ?

RESPONSE: Please refer to Section 4.3.2.3.1 (g) of the BAA regarding FWAs.

QUESTION 5: When would a decision for a grant be taken? Does NIH/NIAID also have a BAA that is a “fast-track type”? If so, when would a decision for a “fast-track type” grant be taken?

RESPONSE: This solicitation is for the award of a contract not a grant. As stated in Section

3.2.2.1. of the BAA, contract awards are anticipated to be made in or around May 2022.

3) RESEARCH AREA 003:

QUESTION 1: 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?

RESPONSE: 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.

QUESTION 2: Is it mandatory to include a clinical study or clinical trial to be in scope of research area 003?

RESPONSE: It is not mandatory to include a clinical study or clinical trial to be in scope for Area of Research 003. It is expected, though, that funded development of the test system will include clinical specimen testing and initial validation.

QUESTION 3: Could you please clarify for research area 003 what low and high-throughput means? “Be designed either for low-throughput use in near-patient settings such as physician’s office, community pharmacy, and hospital emergency room, or for high-throughput or rapidly scalable use in hospital laboratories or central reference testing labs.”

RESPONSE: Near-patient solutions are expected to be low-throughput, 1-10 patient samples per sequencing run. Laboratory-automated solutions are expected to be higher-throughput, 100-1000 patient samples per sequencing run.

QUESTION 4: Could you please clarify the expectation by the end of the period of performance to ‘Generate actionable diagnostic results within 1-2 hours without additional manual intervention’?

Given the ambitiousness, would NIAID consider something with a higher sample-to-result time?

RESPONSE: The stated objective is to achieve an actionable result beginning from initial sample processing through data interpretation within two hours, which is not currently achievable. Methods that make progress toward achieving that objective may be given consideration.

QUESTION 5: One key question is in the objective on page 15, under the technical objective of Research Area 003 is stated “Turnaround time – pathogen ID within 1-2 hours of specimen

HHS-NIH-NIAID-BAA2021-1 Page 6 of 6 Amendment One (1) collection”. One page 16 it is stated that solution: “Be designed either for low-throughput use in near-patient settings such as physician’s office, community pharmacy, and hospital emergency room, or for high-throughput or rapidly scalable use in hospital laboratories or central reference testing labs.”

Since it is not possible to have a result within 1-2 hours of collection for a test that is conducted at a central reference laboratory, is a reference lab solution within the scope of the program or is it limited to “within 1-2 hours of specimen collection”?

RESPONSE: For higher-throughput, laboratory-automated conditions, the expectation of a result within 1-2 hours assumes beginning with initiation of sample processing and concluding with final interpreted result.

QUESTION 6) The solicitation indicated that sequencing diagnostics must return results in 1-2 hours; however, high-throughput NGS diagnostics typically take 5-7 hours just for the sequencer step. Can the government clarify this point? Will workflows that exceed 2 hours from sample to result be allowable?

RESPONSE: The objective is not to replicate current methods and required times to obtain actionable results, but rather to improve dramatically on current state-of-the-art in processing, run, and analysis times. Proposed workflows whose final goal will be longer than two hours from initiation of sample processing to interpretable result may be considered.

QUESTION 7: I have read the BAA and have a question that was not totally clear to me. The requirements suggest that an automated, liquid handling workflow is needed. There is no equipment allowed on the grant, so I’m assuming that the proposal should include the development of a device to facilitate these activities? Is there a cost constraint in the device that should be considered if it is intended to be used in a clinical setting?

RESPONSE: The funding mechanism is contract awards, not grants. The solicitation seeks proposals that meet the expectations laid out in the solicitation for the purpose of negotiating a contract with the developer. There is no expectation to design, develop, and manufacture an automated liquid handling device. Solutions that require ancillary laboratory equipment are expected to utilize commercially available hardware common to laboratories that will deploy the test. No funding will be available for hardware development.

Request to Sponsor an IND/IDE for a DMID-Funded Clinical Trial

Requestor’s Name, Title, Address:

DMID protocol number, if available: _________________________ Protocol Title:

Request that DMID provide support services such as DMID clinical trial sites, data management, or site monitoring yes no Requesting institution and any subcontractors/collaborators engaged in clinical research have a Federal Wide Assurance (FWA): yes no Type of Product:

Vaccine Therapeutic Device Other

Regulatory History:

Existing IND/IDE for this product(s): yes no If yes, IND/IDE number(s) ________________; Sponsor _______________________________________

Study will be conducted under an existing IND/IDE Study will be conducted under a new IND/IDE

Rationale for sponsoring the IND/IDE:

Name/address of proposed:

Clinical trial site(s):

Data management:

Clinical site monitor:

Previous experience as IND/IDE sponsor, including other NIAID-funded studies, if applicable:

Description of regulatory support staff:

Description of clinical support staff:

Additional comments:

Signature Date

For DMID use only Program Comments and Recommendation