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

HHS-NIH-NIAID-BAA2023-1

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NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Nine (9)

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 Nine Issuance: March 21, 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.

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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 NINE (9)

The purpose of Amendment Nine (9) is to:

I. Revise response to Question 5 under General Questions applicable to all Research Areas of

Amendment Six.

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. General Questions applicable to all Research Areas:

Question 1 (General Question 5 of Amendment Six): Are Phase 1 and/or Phase 2 clinical trials required for Research Areas 002 and 003?

Response: Clinical trials are not required for proposals that include lead optimization; however, proposals that do not include Lead Optimization are expected to complete evaluation in a Phase

1 or Phase 2 clinical trial within the 5-year proposed period of performance. See Section 3.3.2.2 and 3.3.3.2 of the BAA.

Question 2: Can you please define and distinguish between subcontractor and consultant?

mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov

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Response: In accordance with FAR 52.244-2, subcontract means any contract, as defined in

FAR subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

In accordance with FAR 31.205-33, “Professional and consultant services," as used in this subsection, means those services rendered by persons who are members of a particular profession or possess a special skill and who are not officers or employees of the contractor.

Examples include those services acquired by contractors or subcontractors in order to enhance their legal, economic, financial, or technical positions. Professional and consultant services are generally acquired to obtain information, advice, opinions, alternatives, conclusions, recommendations, training, or direct assistance, such as studies, analyses, evaluations, liaison with Government officials, or other forms of representation.

Question 3: Are companies or vendors that provide a fee-for-service, where they do not work on the proposal, and where they provide similar goods/services to others as part of their business, considered consultants?

Response: Please see response for Question 2 above for the definition of a consultant.

Question 4: What is the difference between a grant and a contract concerning the required release of information to the public? Would we need to disclose any information during the contract period that could potentially harm a claim to intellectual property?

Response: Any recipient of federal support, such as grant and contract, is subject to the Freedom of Information Act (FOIA). The FOIA provides the public the right to request access to records from any federal agency. Federal agencies are required to disclose any information requested under the FOIA unless it falls under one of the nine exemptions which protect interests such as personal privacy, national security, and law enforcement. For more information, go to FOIA

FAQ at: https://www.foia.gov/faq.html. With respect to releasing information on an offeror’s proposal submitted in response to a competed solicitation, please see response to General

Question 1 of Amendment Seven for further information.

An offeror that includes in their proposal data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, please see Section 4.1.2 of the BAA for guidance.

Post-award, an awardee is required to report to the U.S Government all inventions made in performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act). Please see response to General Question 5 of Amendment Eight for additional information.

Question 5: If the primary investigator is already listed in a foreign government grant, would they be eligible to apply? In addition, if that government grant supports the development of an identical drug product but a different target indication, would this proposal be considered?

Response: A principal/primary investigator (PI), not otherwise listed in the exclusion record in

SAM.Gov, may work on more than one award. However, the PI’s effort/time may not exceed

100% of total awards. A contract to develop a product that differs only by indication from another development program in your organization is allowed but may introduce compliance challenges during contract administration. Please understand that this solicitation will result in a https://www.foia.gov/faq.html

Page 4 of 6 Amendment Nine (9) contract and not a grant. Direct costs may not support any work outside the contracted work. For example, labor costs and chemical supplies, including intermediates and product batches purchased or produced under this contract may not be used to support work outside the contract, even if it would be the most efficient use of time and resources.

Question 6: For the options that are included (IND Submission, Phase 1, Phase 2), is there a maximum budget that we should be aware of or is appropriate cost justification in the business proposal substantial enough to the reviewer for preliminary budget acceptance?

Response: An offeror should propose a budget that is aligned with the Statement of Work proposed and the initial proposal should contain the offeror’s best terms from a price and technical standpoint. 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. See Section

4.3.3. of the BAA. Please note that only the Technical Proposal is evaluated by a peer review group.

Question 7: In amendment 7, Sec. I, Subsec. A, Question 2, it is asked if a sample of a past application can be provided. Could a sample template be provided instead? We are looking to acquire more guidance than what is available in Section 4.3.2. and on the NIH website.

Response: There is no sample template for the Technical Proposal as the specific technical requirements and performance specifications are to be developed and proposed by the offeror, not the Government. See Section 1 of the BAA. However, a template for the SOW in tabular form for Research Areas 001, 002, 003 is provided in Section 4.3.2.2 SECTION 5: STATEMENT OF

WORK FORMAT.

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 (Sections 4 and 5) and a description of the evaluation and award process

(Section 6); and exercise its professional judgement in compiling its proposal.

Question 8: Is the 11th April a hard deadline for all applications or is there anyway the deadline can be extended?

Response: Yes, the proposals due date of April 11, 2023, 3:00pm ET for Research Areas 001, 002, and 004 is the hard deadline and will not be extended.

Question 9: Will compliance to Cost Accounting Standards (CAS) be a hard requirement?

Response: Negotiated contracts not exempt in accordance with 48 CFR 9903.201-1 shall be subject to CAS. A CAS-covered contract may be subject to full, modified, or other types of CAS coverage. See 48 CFR 9903.201-1 at: https://www.ecfr.gov/current/title-48/chapter-

99/subchapter-B/part-9903/subpart-9903.2/section-9903.201-1 for categories of contracts and subcontracts that are exempt from all CAS requirements.

Question 10: Generally, FAR has extensive flow down requirements for subcontractors to the

Prime and given that we are a commercial enterprise, it can be quite challenging achieve full compliance with our subs. Will your office consider any case by case exceptions to FAR flow downs or do you expect all performers to meet all of FAR?

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Response: There are no case by case exceptions; all mandatory FAR clauses must flow down to your subcontractors. The organizational structure of the successful offeror will determine the specific general clause listing to be contained in the contract awarded from this BAA. See Section

5.49 of the BAA.

Question 11: If we are awarded a contract, can we later transfer the contract and funding to another company?

Response: 41 U.S.C.6305 prohibits transfer of Government contracts from the contractor to a third party. The Government may, when in its interest, recognize a third party as the successor in interest to a Government contract when the third party’s interest in the contract arises out of the transfer of-

(1) All the contractor’s assets; or

(2) The entire portion of the assets involved in performing the contract. (See 14.404-2(l) for the effect of novation agreements after bid opening but before award.) Examples of such transactions include, but are not limited to-

(i) Sale of these assets with a provision for assuming liabilities;

(ii) Transfer of these assets incident to a merger or corporate consolidation; and

(iii) Incorporation of a proprietorship or partnership, or formation of a partnership.

See FAR 42.1204 for further information.

B. RESEARCH AREA 001

Question 1a: For an adaptive Phase 1-2 trial that is designed to identify the optimal dose in the

Phase 1 cohort and designed to expand the safety database in the Phase 2 cohort prior to a Phase 3 trial, would the BAA consider funding just the “Phase 1 cohort” or would both cohorts of the

Phase 1-2 trial be included in an award, potentially as an option for the Phase 1 cohort and an option for the Phase 2 cohort.

Response: Research Area 001 focuses on the advancement of a promising lead vaccine candidate from pre-clinical testing through evaluation in a Phase 1 or Phase 2 clinical trial. See Section

3.3.1.2. - Technical Approach

Question 1b: Is there a maximum sample size limit that will be considered for a Phase 1 cohort?

Response: No, but the size of the cohort needs to be scientifically justified. We don’t expect the size to achieve statistical significance.

Question 2: Research Area 001 includes the development of vaccine candidates for BioDefense and Emerging Infectious Diseases. The pathogens listed include pan-coronaviruses, SARS-C0V-

2, alphaviruses, filoviruses, orthopoxviruses, and coccidioidomycosis. Will combination vaccines

(e.g., COVID-19 + influenza) be considered for funding under this BAA under research area 001?

Response: No. Please see Section 3.3.1.1 - Technical Objectives. This research area is restricted to specific pathogens. Combination vaccines would have to include only the following pathogens:

• Pan-coronavirus vaccines that provide broad and ideally durable protective immunity, preference for candidates that incorporate novel immunogens

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• SARS-CoV-2 variants of concern vaccine that elicits mucosal immunity and has demonstrated preclinical efficacy as shown by reduction of viral replication in the upper respiratory tract

• Alphaviruses (excludes Chikungunya)

• Filoviruses: Sudan, Marburg (excludes Zaire; adenovirus and recombinant vesicular stomatitis virus (rVSV) vectored platforms)

• Flaviviruses (excludes Zika, Dengue)

• Orthopoxviruses: Especially next generation vaccines for smallpox (must also protect against monkeypox and excludes Modified Vaccinia Ankara (MVA)-based technologies) suitable for all ages and the immunocompromised

• Valley Fever (Coccidioidomycosis)

C. RESEARCH AREA 004

Question 1: In the first paragraph of Section 3.3.4.1.(3), the BAA says that we can choose either

“genotypic antimicrobial resistance prediction OR phenotypic antimicrobial susceptibility testing

(AST). Then, in Section 3.3.4.2. – Technical Approach, it lists the organisms that we can investigate, but after each organism list “including genotypic resistance markers” as the only option, so the two sections do not match. Can you please confirm that each organism (i.e., ESKAPE pathogens) should also have the option of including genotypic resistance markers OR phenotypic AST characterization?

Response: In Section 3.3.4.2, under Technical Approach, details in the bacterial ID for ESKAPE pathogens should include genotypic AMR prediction and/or phenotypic AST characterization.