Amendment Four HHS-NIH-NIAID-BAA2020.pdf

HHS-NIH-NIAID-BAA2020-1 Page 1 of 4 Amendment Four (4)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT Four (4)

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-BAA2020-1

Date of Solicitation Issuance: January 3, 2020

Date of Amendment Four (4) Issuance: February 13, 2020

Number of Pages: 4

Proposal Due Dates:

The hour and date specified for receipt of offers for each Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE RECEIPT DATE AND

TIME

001 DAIT Development of Radiation/Nuclear Medical Countermeasures (MCMs)

3:00 PM Eastern Time, 04/09/2020

002 DMID Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68

3:00 PM Eastern Time, 02/28/2020

003 DMID Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

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

3:00 PM Eastern Time, 04/09/2020

005 DMID Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

3:00 PM Eastern Time, 04/09/2020

Points of Contact:

Division of Allergy, Immunology, and Transplantation (DAIT) Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Liem Nguyen, Contracting Officer Email: liem.nguyen@nih.gov Phone: 240-669-5144 mailto:liem.nguyen@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 2 of 4

Division of Microbiology and Infectious Diseases (DMID) Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis Associated with Enterovirus D68 Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

Primary Contact:

Swee L. Teo, Contracting Officer Email: teosl@niaid.nih.gov Phone: 240-669-5173

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

The purpose of Amendment Four is to:

I) Provide responses 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. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

mailto:teosl@niaid.nih.gov mailto:brian.madgey@nih.gov

HHS-NIH-NIAID-BAA2020-1 Page 3 of 4

I.) The Government’s responses to questions received regarding this solicitation are as follows:

Division of Microbiology and Infectious Diseases (DMID)

GENERAL QUESTIONS

Question 1: The opportunity requires a Small Business Subcontracting plan which include a requirement for 33% subcontracted to small business across multiple categories. It is not clear whether the 33% is a percentage of the total contract value over the period of performance or if it is 33% of the total subcontracted dollars over the same period?

Response: Please refer to Section 7 - Attachment 8 – Small Business Subcontracting Plan of the BAA and follow the directions provided in the template.

Section 2.a. of the Template states “Total dollars planned to be subcontracted under this contract.”

Section 2.b. of the template states “Total dollars planned to be subcontracted to small business concern”

– (Percentage of 2a).

Please complete these fields (2.b, 2.c, 2.d., 2.e, 2.f, and 2.g.) based, at the very least, upon the minimum subcontracting goal percentages as established in Section 4.3.3.1.6 of the BAA. If you proposal includes options, please sure to break out the base period and any options as requested for each section.

Research Area 002: Advanced Development of Vaccine Candidates for Acute Flaccid Myelitis (AFM) Associated with Enterovirus D68

Question 1: Will a proposal be rejected if a Phase I clinical trial is not included in the Technical Approach?

Response: As stated in Section 3.2.2.1.3 – Technical Approach “ Research Area 002 will support the development of inactivated EV D68 vaccines through a Phase I clinical trial.”

Based on the language provided in the solicitation, a Phase I clinical trial is a requirement of this Research Area.

Research Area 004: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases

Question 1: Our organization is developing an anti-viral compound with an extended half-life that can also be administered pre-exposure to provide universal influenza protection lasting several months.

While we have strong pre-clinical data supporting use of our compound for treatment of influenza, we are very interested in pursuing the prophylactic use instead of a more traditional therapeutic program (that is, prevent people from falling sick versus waiting for them to get sick and then treat). For RA 004, the solicitation states compounds must either cure or mitigate the disease after symptoms arise. Can

HHS-NIH-NIAID-BAA2020-1 Page 4 of 4 prevention also be included in that definition and be eligible? To be clear, this compound is not a vaccine and does not elicit immunity against the virus.

Response: As stated under Section 3.2.2.3.2. Technical Objectives: “The objective of Research Area 004 is the development of promising new therapeutics to address infections caused by NIAID Category A, B, and C priority pathogens. For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident.” Thus, prophylactic use of a therapeutic candidate is not preferable under this BAA RA 004, but is not excluded from consideration, provided that the candidate has the ability to cure or mitigate the infectious disease of interest.

PLEASE NOTE: In the questions/responses above, specific organizational names have been removed or replaced where possible as well as other minor adjustments.