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

HHS-NIH-NIAID-BAA2023-1

Page 1 of 3 Amendment Ten (10)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Ten (10)

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 Ten Issuance: March 28, 2023

Number of Pages: Three (3)

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 3 Amendment Ten (10)

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 TEN (10)

The purpose of Amendment Ten (10) is to:

I. As stated in Amendment One, the cut-off date for questions for Research Areas 001, 002, and 004 is March 30, 2023. The Government cannot guarantee a response for questions submitted after this date.

II. 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. RESEARCH AREA 004

Question 1: In preparing our submission in response to HHS-NIH-NIAID-BAA2023-1 Area 004, we have been somewhat confused by the instructions for the technical proposal provided in the solicitation.

The instructions specify several sections with suggested page lengths:

• Outline of Technical Plan (suggested 15-page max)

• Statement of Work Format (2 pp)

• Statement of Work Technical Discussion (25 pp) mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov

Page 3 of 3 Amendment Ten (10)

The SOW is supposed to include:

A. Product Development Plan, including as applicable:

1. Diagnostic Development

2. Integration and Optimization of Diagnostic

3. Initial Diagnostic Testing Using Human Clinical Samples Containing Virulent Pathogens – pre-existing human clinical samples or human samples spiked with virulent pathogens

4. Diagnostic Manufacturing

5. Clinical Feasibility Testing Using Prospectively Collected Samples

B. Work Plan

C. Regulatory Interactions, Quality Control, Assurance and Data Management

D. Project Management

E. Communications and Contract Review Meetings

F. Reports and Deliverables

The Work Plan itself includes:

1. Base, options & milestones for key project objectives

2. Threshold decision gates

3. Timelines

4. Gantt chart

5. Tech approach

6. Mfg, FDA studies

7. QC

8. Risk mgmt

9. Data sharing

10. Tech proposal cost summary include subcontracts

11. Subcontractor & consultant tasks

12. Direct cost & resource info

The instructions are unclear. Clearly the PDP, Work Plan, and rest of the SOW cannot be done in

2 pages. Are these meant to be part of the Outline of the Technical Plan or part of the SOW

Technical Discussion?

We are trying to follow the template specified in the solicitation, but do not understand how to structure our submission properly. Could you clarify this for us?

Response: The Statement of Work Format is meant to describe a high-level outline (usually tabular) of the major technical efforts of the proposal (Sec. 4.3.2.2, pages 46-48, Sample

Statement of Work for Research Areas 001, 002, and 003, and Sample Statement of Work for

Research Area 004). The number of pages for the SOW, including each Section 2-9 is a suggestion and may be revised. However, pages in excess of the 75-page limitation will be removed from the proposal.

Section 6: Statement of Work Technical Discussion should include detailed documentation to demonstrate how you will accomplish the work in your proposed SOW, including the detailed elements of the Work Plan.

The Outline of the Technical Plan should include sufficient detail to assess the proposed plan, as applicable to the research area, including a table that clearly identifies all proposed subcontractors. Subcontractors’ activities should also be clearly identified throughout the technical plan. Key specifications, decision points, and risk mitigation should also be included

(page 45, Section 4 Outline of Technical Plan).