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

HHS-NIH-NIAID-BAA2023-1

Page 1 of 6 Amendment Five (5)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Five (5)

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 Five Issuance February 17, 2023

Number of Pages: Six (6)

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 6 Amendment Five (5)

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 FIVE (5)

The purpose of Amendment Five (5) 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: Re: 4.3.3.1.4 – Requirement for Certified Cost or Pricing Data and Data Other than

Certified Cost or Pricing Data, FAR Clause 52.215-20:

o The 2023 Solicitation cites the October 2010 version of the FAR Clause.

o The 2022 Solicitation cited the November 2021 version of the FAR Clause.

o Which FAR Clause version should be cited?

Response: Section 4.3.3.1.4 has been revised to reflect the most current version of FAR Clause

52.215-20, that is, Nov 2021, in Amendment Four (4) issued on SAM.Gov.

Question 2: The spreadsheet linked on page 74 of the Solicitation Document “Breakdown of

Proposed Estimated Costs (plus fee) and Labor Hours” links to an Excel file with OMB Control

No. 9000-0013 Updated 10/9/2008 (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx). However, Attachment 8, Page 125 links here:

mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

Page 3 of 6 Amendment Five (5) https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j. This page then leads to an Excel file (https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx), with the same title as above and with the same OMB Control No. 9000-0013, but with a different

“updated date” of 08/06/2014.

Which version of the spreadsheet should we use?

Response: An offeror shall use the “Breakdown of Proposed Estimated Costs (plus fee) and

Labor Hours” Excel file located at: http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx for the summary budget reflecting the total costs over the period of performance of the proposed contract. See Section 4.3.3 (page 74) of the BAA. Please note that this Excel file is the same excel file as in https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx.

The link for Attachment 8 is to provide the template for the Small Business Subcontracting Plan, if applicable. See “HHS Subcontracting Plan Template” under the “Solicitation Attachments” of this website.

Question 3: Do we need to include cost data and all cost related support in the Business

Proposal?

Response: The Business Proposal must contain sufficient information to allow the

Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price.

These elements shall include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit. See Section 4.3.3 of the BAA.

Question 4: As some of our studies are ongoing, and we may receive data or results relevant to the BAA after our submission: Are we allowed to provide more relevant data after submission as it becomes available?

Response: No. Offerors will be unable to revise their proposal after the closing date and time specified in the BAA. Your technical proposal will be evaluated by a peer review group against the evaluation criteria identified in Section 6.3 of the BAA.

As stated in Section 6.1 of the BAA, following the proposal evaluation, the Government will conduct negotiations with selected offerors to address identified weaknesses, questions, and areas for clarification, as well as to refine the proposed SOW and deliverables.

Question 5: As some of our studies are ongoing, how should we present or represent relevant data that is currently being compiled, or studies that are in progress?

Response: An offeror shall exercise its professional judgement when compiling its proposal. A

Technical Proposal must demonstrate the feasibility of its approach and its relevance to the appropriate Research Area (Section 3) and the technical requirements of the BAA (Section 4). An offeror must submit information sufficient to evaluate its proposals based on the detailed criteria as described in Section 6 of the BAA. The merit of each proposal will be evaluated by a peer review group. Thus, an offeror must demonstrate in its proposal that it has adequate information https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

Page 4 of 6 Amendment Five (5) necessary for the evaluation of the candidate product. The technical proposal may discuss ongoing and planned studies in the context of the overall research plan for the program.

Question 6: Some of the key personnel for our proposed work have not yet been hired, although they have committed to work with us. How do we present this?

Response: An offeror shall exercise its professional judgement when compiling its proposal. An offeror shall furnish all necessary services, qualified professional, technical, and administrative personnel, material, equipment, and facilities, not otherwise provided by the Government, to perform the tasks proposed in the Statement of Work. See Section 4.3.2.2 (page 45) of the BAA.

An offeror must submit information sufficient to evaluate its proposal based on the detailed criteria as described in Section 6 of the BAA. The merit of each Technical Proposal will be evaluated by a peer review group. Thus, an offeror must demonstrate in its proposal that it has or will have the necessary expertise and capabilities for conducting the proposed research.

Commitment letters and biosketches from proposed personnel may be included in the relevant sections of the technical proposal. See Section 4.3.2.2. of the BAA

B. RESEARCH AREA 002

Question 1: Under section 3.3.2 - Research Area 002 - Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases, subsection

3.3.2.4 clause 4, if an offeror is developing an alternate route of administration and formulation of an approved and marketed known drug class that has demonstrated substantial improvements in safety and efficacy (based on non-clinical and case report type clinical data) over existing FDA approved and marketed products, would the offeror’s proposal be eligible for submission under this BAA?

Response: No. A contract awarded in this Research Area will not support development of a product that is derived from, substantially similar to, or identical to an entity that has ever been part of a commercially available human consumable product in any jurisdiction worldwide. See

Section 3.3.2.4 Item 5.

Question 2: If I propose lead optimization for the base period and IND enabling studies as an option as seems to be required, how much detail is needed for the option period at the time of submission? It is difficult to prepare a manufacturing plan without knowing the final identity of the compound. Similarly, IND enabling studies are difficult to plan without knowing the compound and appropriate doses to test.

Response: An offeror shall exercise its professional judgement when compiling its proposal. A

Technical Proposal must demonstrate the feasibility of its approach and its relevance to the appropriate Research Area (Section 3) and the technical requirements of the BAA (Section 4). An offeror must submit information sufficient to evaluate its proposals based on the detailed criteria as described in Section 6 of the BAA. The merit of each Technical Proposal will be evaluated by a peer review group. Thus, an offeror must demonstrate in its proposal that it has adequate information necessary for the evaluation of the candidate product.

In proposing performance periods for the Base and each Option, an offeror should make a reasonable estimate of the time in months and resources that would be needed to complete the activities under the Base and each Option. The total performance period comprised of combined

Page 5 of 6 Amendment Five (5)

Base and all options proposed by an offeror should not exceed five (5) years. See Section 3.2 of the BAA.

Question 3: One of the check boxes on Attachment 16 specifies that: “The product does not require device development”. The product we are developing is a drug/device combination, but the device itself has already been developed (and we have tested the combination). However, the device is not commercially available, but rather is a custom design of our own. How is one to interpret the word “developed”?

Response: Development work in this context is any work required to achieve FDA clearance of the device as a new medical device. A contract awarded under Research Area 2 can support a product requiring a device for administration but cannot support development work on a device.

See Section 3.3.2.4 Item 9.

Please note that Attachment 16 is provided as a checklist only to aid offerors in determining if the

Technical Proposal meets Research Area 002 requirements and exclusions. 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), instructions regarding the proposal submission

(Section 4) and a description of the evaluation and award process (Section 6); and exercise its professional judgement in compiling its proposal.

Question 4: Is in vitro and in vivo demonstration of therapeutic activity required in all seven serotypes required for the lead molecules? If we have demonstrated therapeutic activity in only some serotypes, is this sufficient preliminary data for eligibility?

Response: Stage-appropriate data must be provided. For proposals that include Lead

Optimization, stage-appropriate data demonstrates achievement or near-achievement of preclinical candidate selection criteria by exemplars of the proposed lead series. See Section

3.3.2.3 Item 1.

Question 5: We recently submitted an ‘expression of interest’ to CARB-X in order to seek funding for one of our IND-enabling studies in the therapeutic category. If our EOI is accepted by

CARB-X, we will be asked to submit a full proposal on or before March 27, 2023. We wonder if we can simultaneously submit a funding application to NIAID for the same study under the omnibus BAA, issued on Jan 11, 2023.

Response: Yes, an offeror may submit proposals to various funding announcements simultaneously. If the specific goals and objectives differ, an award can be made to an offeror that has ongoing support from other NIH, or government agency, or government-supported sources. However, the NIAID will remove any portion of a proposal that overlaps with research that is underway or completed.

Please note that if multiple contracts are awarded by NIAID, an offeror should assure that the principal investigator, and all other personnel proposed, shall not be committed on federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed employee is committed for more than 100% of his or her time, the government will require action on the part of the offeror to correct the time commitment. See

Section 4.3.2.2, Section 7 (page 50) of the BAA.

C. RESEARCH AREA 004

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Question 1: What is included under the “novel coronavirus (Coronoaviridae)” category of viruses?

Response: Novel coronavirus may include SARS-CoV-2 omega subvariants, MERS, SARS-CoV, and any other emerging human pathogenic coronavirus known or, as yet, unknown (yet possibly identifiable by targeting the most conserved regions of Coronaviridae). Not included in these would be seasonal coronaviruses, 229E, NL63, OC43, HKU1.

Question 2: Is the development of an assay for rapid identification of all ESKAPE pathogens directly from whole blood which does not provide information regarding resistance/susceptibility in scope?

Response: A bacterial ID test direct from whole blood that is not linked to antimicrobial resistance (AMR) or antibiotic susceptibility testing (AST) is not in scope, per Section 3.3.4.1, item #3, page 17: "The third objective of Research Area 004 is…identification of microbial infection coupled with either genotypic antimicrobial resistance prediction or phenotypic antibiotic susceptibility testing…."

Question 3: In the solicitation, under 3.3.4.2- Technical Approach, it states: “Diagnostic test system must detect one of the following agents:”

“ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp), including genotypic resistance markers.” In case our diagnostic assay detects some of the ESKAPE pathogens but not all, are we eligible to apply and within scope of the solicitation?

Response: Submissions that propose to target one or more, but not all, of the ESKAPE pathogens direct from biological specimen are in-scope provided they are coupling bacterial ID testing with either genotypic AMR prediction or phenotypic AST, as per Section 3.3.4.1, item #3, page 17:

"The third objective of Research Area 004 is…identification of microbial infection coupled with either genotypic antimicrobial resistance prediction or phenotypic antibiotic susceptibility testing…."