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

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

Amendment Eight (8)

NIAID 2020 OMNIBUS BROAD AGENCY ANNOUNCEMENT

HHS-NIH-NIAID-BAA2020-1

AMENDMENT EIGHT (8)

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

Eight (8) Issuance: March 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

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 Eight 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.

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

GENERAL QUESTIONS

Question 1: The BAA omnibus states that the NAICS code for this acquisition is 541715 [Research and

Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and

Biotechnology)]. Is NAICS code 541714 [Research and Development in Biotechnology (except

Nanobiotechnology)] acceptable?

Response: Yes, all offerors, not otherwise prohibited by law, are eligible to respond to the subject BAA.

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

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Question 2: BAA Section 4.3.2.1.3 – Formatting and Page Limitations f. Spacing shall be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

Usually we provide for NIAID: 10 pt minimum Times New Roman for narrative (i.e., Headers may be larger); Single-Spaced; Graphics and Tables can be 9pt in Arial and/or TNR; 1” Margins

Can you please confirm that this will be acceptable?

Response: Formatting of proposals must comply with Section 4.3.2.1.3 (page 61).

SPECIFIC RESEARCH AREA QUESTIONS

Division of Microbiology and Infectious Diseases (DMID)

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

Question 1: Do we need to have firm and final budgets from Contract Research Organizations in order to submit a Business Proposals, or, are estimated costs good enough with final negotiation during the negotiation period with the NIAID?

Response: An offeror’s initial proposal should contain the offeror’s best terms from a price and technical standpoint.

Question 2: Can you direct me on where to enter our proposal?

Response: For this solicitation, NIAID requires proposals to be submitted online via the electronic Contract Proposal Submission (eCPS) website: https://ecps.nih.gov/. Submission of proposals by any other method is not permitted. Please review Section 4.3.2.1 – Proposal Submission Instructions (starting page 60) of this BAA.

Question 3: We have a therapeutic dressing with antimicrobial properties against pathogens outlined in

Research Area 004 that has been classified as a FRO category 2 medical device following a 510(k) pre-market clearance regulatory pathway. Although it is considered a drug/medical device category we have not yet determined if we will be filing an IND. Would we qualify to apply for this contract with a FRO medical device?

Response: This BAA excludes topical use of therapeutics. Additionally, Section 3.2.2.3.5 states, “Contracts awarded under this Research Area will NOT support:

• Development of devices.

Question 4: For Research Area 004, the omnibus provides the following guidance for Preliminary Data Requirements:

“Regardless of the proposed entry point, therapeutic lead series/lead/product candidate must show demonstrated, phase-appropriate evidence of all the following characteristics:

• Synthesis/manufacturing feasibility;

• Appropriate in vitro AND in vivo efficacy; and https://ecps.nih.gov/

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• Appropriate in vitro AND in vivo pharmacokinetic and toxicology.

These characteristics must be reflected in the draft Target Product Profile (TPP)”

Since Lead Optimization is one of the development phases that is in-scope for Research Area 004, we need clarification on the Preliminary Data Requirements. At the Lead Optimization stage, one would not typically have “in vivo efficacy” Preliminary Data. The Preliminary Data Requirement asks for “phase-appropriate evidence of … in vivo efficacy … [and] These characteristics must be reflected in the draft Target Product Profile (TPP)”. Are we correct to interpret this as: Our proposed project satisfies the Preliminary Data Requirements even if we do not have in vivo efficacy at the start of the project, but we must propose it (in vivo efficacy experiments) to provide phase-appropriate in vivo efficacy data during the execution of the project so that it is reflected in the draft TPP? e.g., for a project entering at Lead Optimization, the omnibus states: “demonstrate in vivo activity and potential for efficacy consistent with the product's intended use” is listed as part of the scope – as part of the scope, it cannot also be part of the Preliminary Data Requirement.

Response: A lead optimization program cannot begin without in vivo data to support what needs to be optimized. As such, a proposal must meet the criteria as stated in the Preliminary Data Requirement of Section 3.2.2.3.2 – Technical Objectives (pages 22-24).

Research Area 005: Advanced Development of Diagnostics for Biothreats and Emerging Infectious Diseases

Question 1: I have read NIAID Notice Number: NOT-AI-20-025 but I cannot decipher how an application is submitted. I could not find the announcement listed in Grants.gov.

Response: The solicitation for the Omnibus BAA is listed in Beta.Sam.Gov. Please see link to the BAA below:

https://beta.sam.gov/opp/8476add0be544073a56f97ec196608ba/view?keywords=HHS-NIH-NIAID- BAA2020-1&sort=-relevance&index=opp&is_active=true&page=1

Regarding the submission of an application, please see the NIAID’s response to Question 2 of Research Area 004 above. Please understand that this solicitation will result in the award of a contract, not a grant.

Question 2: For our technology, it is at early, proof-of-concept stage, would it be suitable for this mechanism with respect to its readiness?

Response: A proposal must meet the Preliminary Data Requirements of Section 3.2.2.4.2 – Technical Objectives (page 36) that states, “Initial proof-of-concept demonstration that the diagnostic method can detect a biological component (e.g., pathogen, protein, nucleic acid, etc.), preferably in a relevant clinical matrix (e.g., blood, urine, swab, etc.)”

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

https://beta.sam.gov/opp/8476add0be544073a56f97ec196608ba/view?keywords=HHS-NIH-NIAID-BAA2020-1&sort=-relevance&index=opp&is_active=true&page=1 https://beta.sam.gov/opp/8476add0be544073a56f97ec196608ba/view?keywords=HHS-NIH-NIAID-BAA2020-1&sort=-relevance&index=opp&is_active=true&page=1