Amendment Seven HHS-NIH-NIAID-BAA2020-1 .pdf

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Amendment Seven (7)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT SEVEN (7)

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

Seven (7) Issuance: March 6, 2020

Number of Pages: 5

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

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

Division of Microbiology and Infectious Diseases (DMID) mailto:liem.nguyen@nih.gov

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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 Seven is to:

I) Provide a cut-off date for questions for Research Areas 001, 003, 004, and 005.

II) 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.

I. A cut-off date for questions for Research Areas 001, 003, 004, and 005 is set at March 25, 2020.

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

GENERAL QUESTIONS

Question 1: What are the format and rules governing the preparation of the proposal? How do we prepare the proposal, that is, page length, preparing and formatting the budget, specific requirements, and any related information that we need to know in preparing our proposal?

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

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Response: An offeror should carefully review the content of the BAA for information regarding the technical objective of each Research Area of this omnibus BAA (Section 3 – Research Areas and Technical Objectives), instructions regarding the proposal submission (Section 4 – Instructions, Conditions, and Notices to Offerors and Section 5 – Special Contract Requirements), and a description of the evaluation and award process (Section 6 – Evaluation Factors for Award); and exercise its professional judgement in compiling its proposal.

SPECIFIC RESEARCH AREA QUESTIONS

Division of Allergy, Immunology and Transplantation (DAIT)

Research Area 001: Development of Radiation/Nuclear Medical Countermeasures (MCMs)

Question 1: According to Amendment 5, the Work Plan is not required for Research Area 001. As such, is

Attachment 2–Technical Proposal Cost Summary still required? If so, where should this be included in the proposal?

Response: Attachment 2 – Technical Proposal Cost Summary is still required and should be included in the technical proposal.

Division of Microbiology and Infectious Diseases (DMID)

Research Area 003: Advanced Development of Vaccine Candidates for Biodefense and Emerging

Infectious Diseases

Question 1: Earlier this month Amendment 3 (February 4) and Amendment 5 (February 24) to the BAA have both come out in response to COVID19. The way we read the amendments we now need to have clinical data using our platforms to qualify for consideration. Thus, the bar has moved and NIAID is only funding more advanced platforms. Unfortunately, we do not yet have clinical data with our platform.

Can you confirm that we are now excluded from the NIAID 2020 Omnibus BAA?

Response: To offset the lack of early proof of concept data, critical reagents, and critical assays, COVID-

19 proposals submitted in response to RA 003, are not expected to have proof of concept data for the vaccine candidate or supporting well characterized assays. As a result, COVID-19 proposals will not be subjected to the additional requirements as described in Section 3.2.2.2.4.(I) (page 21). However, the vaccine platform utilized should be well developed with clinical experience, and a defined and scalable manufacturing process that is suitable for use in global pandemic.

Question 2: Is a vaccine for the prevention of urinary tract infections caused by E. coli responsive to

Research Area 003?

Response: Due to the competitive nature of this solicitation, NIAID is unable to provide guidance regarding technical approach. Section 3.2.2.2.2 - Technical Objectives of the Omnibus BAA cites two vaccine objectives for Research Area 003. The first addresses antimicrobial resistance gram negative bacteria focusing, but not limited to, Burkholderia spp., Pseudomonas aeruginosa, Francisella tularensis, Yersinia pestis, and E.coli. The second addresses emerging viruses and pandemic preparedness that includes but is not limited to alphaviruses and bunyaviruses. Amendment #03 to the Omnibus BAA

HHS-NIH-NIAID-BAA2020-1 Page 4 of 5 added vaccine candidates for COVID-19 to Research Area 003 as part of the second objective for pandemic preparedness.

Question 3: If the Offeror solely completes GMP manufacturing with its own funds, can the Offeror request funding solely for Phase 2 clinical trial costs?

Response: Section 3.2.2.2.3 states that proposals should provide “…data to support vaccine development through manufacturing, toxicology testing, and testing in phase I/II clinical trials” and “The scope of the product development activities to be undertaken will depend on the status of the individual candidate product, as well as regulatory requirements.” Consequently, a proposal should clearly distinguish previous work completed and subsequent activities proposed for this BAA. An offeror that proposes a subset of activities, such as a Phase 2 clinical trial, is eligible for this Research Area.

If awarded a contract, only the scope of work and activities detailed therein will be governed by the contract.

Please also note Section 4.3.3.1.21 – Cost Sharing of the solicitation (page 105), which allows Offerors to propose cost sharing under this solicitation. Cost sharing is a cost-reimbursement contract in which the

Government and the Offeror negotiate the share of the project costs eligible for reimbursement under the contract. A cost sharing contract may be used when the contractor agrees to absorb a portion of the costs, in the expectation of substantial compensating benefits. The contractor receives no fee and is reimbursed only for the negotiated portion of its allowable costs. See FAR 16.303.

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

Question 1: Our proposal will NOT include any studies involving human subjects. Are we still required to fill out and include the following attachments in our proposal?

Attachment Title

5 Planned Enrollment Report

6 Protection of Human Subjects Assurance Identification/IRB

Certification/Declaration of Exemption

14 PHS Human Subjects and Clinical Trials Information

15 Study Record: PHS Human Subjects and Clinical Trials Information

If so, what information should we put in the attachments and should they be attached to the technical or business proposal?

Response: If no human subjects are involved, you may enter “N/A” in the PHS Human Subjects and Clinical Trials Information form only (Attachment 14) and upload this document under its folder name in eCPS.

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Question 2: One of the exclusion items states, “Development of candidates/products or lead series that have not demonstrated therapeutic activity in a relevant animal model of disease.” Is it acceptable to rely on animal data for therapeutic activity from a licensed product when the product in development is a new chemical entity that includes the licensed product as an active moiety?

Response: A candidate that is a new chemical entity of which the active moiety (if known) is relatable to the candidate molecule is supported by this BAA. However, if a candidate is a reformulation or new indication of a licensed product, it will not be supported by this BAA.

Question 3: One of the exclusion items states, “Development of licensed products in combination with other licensed products.” Is it acceptable that the product in development, which will be considered a new chemical entity, will include the licensed product as an active moiety.

Response: A candidate that is a new chemical entity of which the active moiety (if known) is relatable to the candidate molecule is supported by this BAA. However, if a candidate is a reformulation or new indication of a licensed product, it will not be supported by this BAA.

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