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

HHS-NIH-NIAID-BAA2023-1

Page 1 of 4 Amendment Eleven (11)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Eleven (11)

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 Eleven Issuance: April 3, 2023

Number of Pages: Four (4)

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.

Page 2 of 4 Amendment Eleven (11)

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 ELEVEN (11)

The purpose of Amendment Eleven (11) 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: The minimum font size requirements will likely cause the level of detail required by the Gantt chart accompanying the SOW table [BAA 4.3.2.2] to result in a multi-page artifact thereby costing valuable space given the 75-page Technical Proposal page limit. Would the

Government consider either lowering the minimum font size for the Gantt chart, allowing 11 x 17 inch pages in the proposal for the Gantt, or allowing bidders to move the Gantt artifact to the

Business Proposal volume?

Response: Proposals submitted in response to the solicitation shall adhere to the formatting and page limitation described in Section 4.3.2.1.3. Failure to adhere to the formatting requirements may impact whether your proposal is reviewed in its entirety.

Question 2: Should the VAS be put into an appendix at the end of the technical proposal, and, if so, does it count toward the 75-page limit? Or should it be submitted as a separate file?

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

Page 3 of 4 Amendment Eleven (11)

Response: The Vertebrate Animal Section (VAS) must be included as a separate section within the Technical Proposal. The VAS is included in the 75-page limitation for the Technical Proposal and must not be submitted as a separate file. See General Question 3 of Amendment Seven, Question 1 under Research Area (RA) 004 of Amendment Ten, and section 4.3.2.5 of the BAA.

Question 3: We are in the process of assembling the Technical Proposal. In reference to Key

Scientific and Technical Personnel, there is a page limit (22 pages) regarding biosketches. Do you have a truncated NIH biosketch format that you can share with me? For instance, we always use the standard NIH biosketch format that goes up to 5 pages; however, this will exceed the page limit.

Response: The 22-page limitation for Section 7: Scientific and Technical Personnel and Project

Management is a suggestion, and offerors may adjust pages to their needs. This applies to other sections in Sections 4.3.2.2 of the BAA as well; however, pages in excess of the 75-page limitation will be removed from the Technical Proposal and will not be considered. Additionally, as stated in this section, you should limit your CVs (or biosketches) to 2-3 pages and provide selected references for publications relevant to the scope of the contract. An offeror may use the attached

NIH Biographical Sketch template.

B. RESEARCH AREA 001

Question 1: We are preparing a submission for the 2023 NIAID Omnibus Broad Agency

Announcement (HHS-NIH-NIAID-BAA2023-1) and on the notice for the BAA it states the following description for area 001 https://grants.nih.gov/grants/guide/notice-files/NOT-AI-23-

025.html:

Description: Supports advancing vaccine candidates, technologies, and platforms that could be deployed against agents that include categories A, B, and C NIAID Emerging Infectious Diseases and Pathogens. Influenza is included in category C.

However, the BAA itself (page 7) for Area 001, does not include this referenced list, nor influenza. This contradiction is confusing. Can our proposal be directed against influenza, specifically pandemic variants including H5N1?

Response: The BAA posted in SAM.Gov is the official solicitation. If there is a conflict between the description posted elsewhere and the official solicitation, offerors shall adhere to the language from the official solicitation and amendments posted in SAM.Gov. Research Area 001 is restricted to the list of pathogens outlined in Section 3.3.1.1. H5N1 is not a pathogen included in the list and therefore would be non-responsive to the BAA.

C. RESEARCH AREA 004

Question 1: For Research Area 004 Objective 1, portability is the key requirement for this objective since it is about the deployability of the final product to be used in as many labs as possible. Our company's non-portable system currently has >80% penetration in the public health lab sector. Proposed contract will expand the current repertoire of pathogens to be detected using our system. Would this high market penetration/presence be able to justify the negation of the need for portability?

Response: The request for portability is less for geographic reach (“deployability”) than for time-to-result potential and ease of use. Penetration with a large number of instruments that are https://grants.nih.gov/grants/guide/notice-files/NOT-AI-23-025.html https://grants.nih.gov/grants/guide/notice-files/NOT-AI-23-025.html

Page 4 of 4 Amendment Eleven (11) still central-lab located and depend on slower second-generation sequence technology may not yield the desired time-to-result expected. Section 3.3.4.1 item #1, p. 16, top, explains that the solicitation is seeking “reduced turnaround time [of] pathogen ID to 2 to 4 hours”. If this can be achieved on larger, lab-located, abundantly placed instruments, then it could achieve the mission to reach sequencing results faster for large numbers of clinical specimens in the short time window of an emerging outbreak.

Question 2: There is a section on automation and is there a requirement to have both nucleic acid extraction and library prep automated. If the requirement is to have both nucleic acid extraction and library prep automated, does the work have to happen on the same instrument or can two different instruments be used?

Response: It is acceptable to propose two different instruments for extraction and library prep.

Question 3: The announcement mentions high throughput methodologies that can process 10+ samples, we are trying to understand if the requirement is more towards 12 sample solutions or 96 sample solutions? Any guidance here is appreciated.

Response: There is no requirement for sequencing throughput. Section 3.3.4.1 item #1, p. 16, top, states, “Areas of focus to improve performance could include, but are not limited to…increased throughput on portable devices [of] > 10 patient samples processed per sequencing run.” Proposing 12 samples is as acceptable as proposing 96 samples per run.

Question 4: There is a requirement for a portable sequencer. Would an Illumina MiSeq or Oxford

Gridion be considered portable? If not, what is considered portable?

Response: A MiSeq, at 94 kg, would not be considered portable. A GridION, at 11 kg, could be considered portable.

Question 5: With respect to pathogen detection, are you looking for solutions that provide detection with 3-4 MM sequencing reads or more like 15 MM reads?

Response: These parameters for sequencing depth, and the justifications to go with them, are at the discretion of the offeror.