Amendment 4 - HHS-NIH-NIAID-BAA2022-1.pdf

HHS-NIH-NIAID-BAA2022-1

Page 1 of 8 Amendment Four (4)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2022 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2022-1

Solicitation Amendment Four (4)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, MSC 9821 Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2022-1

Date of Solicitation Issuance: January 18, 2022

Date of Amendment One Issuance: February 14, 2022

Date of Amendment Two Issuance: February 17, 2022

Date of Amendment Three Issuance: March 16, 2022

Date of Amendment Four Issuance: April 8, 2022

Number of Pages: Eight (8) pages

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

NIAID

DIVISION

TITLE PROPOSALS DUE*

DMID

Development of Vaccine Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases

April 18, 2022

Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging

The Antiviral Program for Pandemics (APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential

March 18, 2022

Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging

Page 2 of 8 Amendment Four (4)

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

Contracting Office Points of Contact:

Primary Contact:

Julie Rodriguez, Contracting Officer Email: julie.rodriguez@nih.gov Phone: 301-761-7735

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 #4

The purpose of Amendment Four is to 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.

GOVERNMENT’S RESPONSES:

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

I. GENERAL QUESTIONS APPLICABLE TO ALL RESEARCH AREAS:

QUESTION 1: Is an organization allowed to submit more than 1 proposal to a Research Area?

RESPONSE: Yes, an organization may submit more than 1 proposal to a Research Area.

QUESTION 2: Are companies required to be registered for Federal contracts at the time of submission or would the time of award be okay?

RESPONSE: The BAA and FAR 4.1102 require offerors to be registered and active in SAM at the time of submission. It is required that all offerors complete the Representations and Certifications in SAM before proposal submission (see Section 4.2.1).

Page 3 of 8 Amendment Four (4)

QUESTION 3: To the extent an awardee will use a subcontractor to perform a portion of the work, must the subcontract be cost reimbursement, or can the subcontract be on a firm‐fixed‐price basis?

RESPONSE: Yes, a subcontract may be firm fixed price if that’s appropriate for the work being performed.

QUESTION 4: Can the Government provide a list of relevant FAR and other clauses that will be included in the award, including any required to be applied to subcontractors?

RESPONSE: The NIAID intends to include the general clauses for R&D requirements in all contract awards resulting from this solicitation.

QUESTION 5: Considering estimated awards occurring in May 2023, would it be acceptable to propose for the Base Period completion to by 1 year for the estimated award (e.g. 5/1/23 – 4/30/24)? I ask because this would put a portion of the Base Period into FY24. Costs provided would be broken by Fiscal Year and Base/Option periods.

RESPONSE: The fiscal year for funding purposes is the one in which the contract/option is awarded. For example, a Base Period of 5/1/23 – 4/30/24 would be funded with FY23 funds because the award was made in the FY 23 fiscal year. Please note that the Government’s fiscal year is from October through September.

QUESTION 6: We feel that we may be more competitive in 3-4 months, and I thought you might have a better idea for the likelihood that this or a similar opportunity come out in the next cycle or in the next year.

RESPONSE: Unfortunately, we cannot confirm whether the BAA will be issued again in 2023 or, if it is, what topics will be covered. It is recommended that you check SAM.gov for future opportunities.

QUESTION 7: The BAA states: “The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this BAA.” Do we need to agree to the terms and conditions at the proposal stage? If so, are we required to list exceptions in the letter signed by AOR?

RESPONSE: Yes; Section 4.3.1.1 states that “the proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this BAA” (emphasis added).

QUESTION 8: Do you need the Small Business Subcontracting Plan at the proposal stage? It is time consuming to complete this document. For subcontract receiving $700k or more from our institution, is this plan required for the sub as well?

RESPONSE: A subcontracting plan is required by the Prime contractor if the estimated cost of the contract (base + options) will exceed $750,000. The plan must be submitted at time of proposal unless you meet one of the exemptions listed in FAR 19.702(b). An offeror’s plan shall include an assurance that all subcontractors, other than small businesses, in excess of $750,000 adopt a plan similar to the plan agreed upon by the offeror. If a subcontracting plan acceptable

Page 4 of 8 Amendment Four (4) to the Contracting Officer is not negotiated within the time limits prescribed the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the offeror, the offeror shall be ineligible for an award.

QUESTION 9: On page 79 of the solicitation, a Certified Cost or Pricing Data index is mentioned. We are not sure what the index means. Is it sufficient to complete Attachment 11‐ “Certificate of Current Cost or Pricing Data” for this section?

RESPONSE: Please review Section 4.3.3.1.3 ‐ Certified Cost or Pricing Data for instructions on providing the required certified cost or pricing data. Attachment 11 is required to certify the required data that is provided.

QUESTION 10: Can we provide a link for our annual financial report and institution travel policy instead of including it in the proposal?

RESPONSE: Section 4.3.2.1.3 – Formatting and Page Limitations, prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

Please note there is no page limit to the business proposal.

QUESTION 11: The Total Compensation Plan talks about “professional employees”. We are not sure if it is applicable for universities.

RESPONSE: Yes, this applies to universities.

QUESTION 12: How much details do you need in Performance History and Pertinent Contracts?

RESPONSE: The level of detail provided is at the discretion of the offeror, but as noted in Section 4.3.3.1.15, “General Experience, Organizational Experience Related to this BAA, Performance History and Pertinent Contracts" should be addressed.

QUESTION 13: If the offeror does not have a federally negotiated indirect cost rate set by the US HHS, is there a standard rate we can use to build the project budget plan?

RESPONSE: There is no standard rate that an offeror should use. However, an offeror should substantiate their rate. Please see Section 4.3.3.1.3 ‐ Certified Cost or Pricing Data, which states, “Show trends and budgetary data to provide a basis for evaluating the reasonableness of proposed rates. Indicate the rates used and provide an appropriate explanation.” Please note that if awarded a contract, the advanced understandings will include the rates proposed as temporary billing rates. Offerors will be required to submit an indirect cost proposal to the cognizant office responsible for negotiating indirect costs after award is made. Failure to submit in a timely manner, will result in indirect costs being suspended.

QUESTION 14: If any efforts including clinical evaluation, industrialization, and FDA submission are outside of the scope of this proposal, shall we still include them?

RESPONSE: Effort should not be proposed for work that is outside of the scope of the proposal.

If it is essential to explain the complete product development story, then information on activities downstream of contract-funded activities may be briefly included. These will not be evaluated in the review of the submission, as they are not part of the in-scope funding activities.

Page 5 of 8 Amendment Four (4)

QUESTION 15: Project management is discussed in both Section D of the SOW and later in Section 6 of the Technical Volume? Should they contain different information?

RESPONSE: As noted in BAA 4.3.2.2, Section 3, the included outline of the SOW should be used by all offeror(s) in the preparation of their Technical Proposals. Thus, project management should be addressed in the Statement of Work. Please refer to BAA SECTION 6: PROJECT MANAGEMENT for the specific requirements of the Technical Volume.

QUESTION 16: Does the NIH consider suppliers who provide commercial services/materials a subcontractor and require Letter of commitment. They are not providing any "development" for our company.

RESPONSE: Section 4.3.3.1.6 defines the term “subcontract” as any agreement (other than involving an employer-employee relationship) enter into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements or purchase orders for supplies and services such as equipment purchase, copying services, and travel services. While Purchase Orders and the like for “off‐the‐shelf” commercial services/materials may not require a commitment letter, the process for identifying, evaluating, and selecting the vendor should be described.

QUESTION 17: We are preparing an HHS-NIH-NIAID-BAA2022-1 proposal after hearing back that we will not receive an award for our HHS-NIH-NIAID-BAA2021-1 proposal. This years proposal will include efforts we proposed in 2021 with some significant revisions, along with some new efforts. Is there some restriction on submission of like proposals to different BAAs and where we might find any further guidance?

RESPONSE: If your proposal has been excluded from consideration for award under the 2021 BAA, and the underlying work has not otherwise been funded, it is not barred from being resubmitted under the 2022 BAA. Please keep in mind that each NIAID solicitation is unique. If you submit a revised proposal, you are encouraged to carefully review the requirements of the research area(s) to which you will apply to ensure that your proposal is responsive.

QUESTION 18: I was wondering whether NIAID could support some experiments (in vivo efficacy studies, microbiology etc.), meaning if we can have some of these experiments performed directly at NIAID as for a collaboration.

RESPONSE: The prime contractor should include in its proposal a plan to provide all required effort to accomplish the work in the SOW. If effort is proposed from those who are not employees of the prime contractor, they should generally either be classified as consultants or subcontractors. Please keep in mind that federal employees are not eligible to receive financial support under a federal contract nor should an offeror propose the use of any NIAID programs or services to complete experiments.

QUESTION 19: When studying an investigational agent, who holds the IND? NIH, the pharmaceutical company sponsor or the institution?

RESPONSE: As stated in Section 3.4.3 of the BAA, “Upon completion of the protocol development, NIAID DMID will determine if the offeror will hold the IND and hold the clinical trial.

Page 6 of 8 Amendment Four (4)

QUESTION 20: Study monitoring is a big expense, and in our past studies this has been handled by NIAID. Should we plan for NIAID to be responsible for this, or should this be under our control and included in our budget?

RESPONSE: No. The prime contractor should include in its proposal a plan to provide all required effort to accomplish the work in the SOW and include all associated cost. If effort is proposed from those who are not employees of the prime contractor, they should generally either be classified as consultants or subcontractors.

QUESTION 21: The BAA suggests that CVs are limited to 2‐3 pages and provide selected references for publications relevant to the scope of the contract. Is the C.V. limited to key personnel only, or to all personnel devoting percentage of effort?

RESPONSE: It is a decision of the Offeror to determine which information is relevant to provide, including submission of CVs, to adequately document the individual training, experience, qualification, and expertise of personnel for the successful completion of the proposed SOW. Please keep in mind the technical page limit of 150 pages includes CVs.

QUESTION 22: Can you confirm whether or not FDA correspondence is counted toward the page count?

RESPONSE: Everything not specifically excluded in Section 4.3.2.1.3 of the solicitation will contribute to the total page count of the technical proposal.

QUESTION 23: I was unclear on the subcontractor portion of the contract, if I needed to submit the excel spread sheet Info also? Or can I just add the total of each year into my Summary.

RESPONSE: BAA Section 4.3.3.1.1 requires that the business proposal “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 will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit.” This also applies to subcontracts proposed, so for cost reimbursement subcontracts, that would include a full budget breakdown in excel.

QUESTION 24: We see that URLs are not allowed but are videos of the proposed technology allowed if they are embedded within the PDF?

RESPONSE: Unfortunately, an embedded video is not allowable. This is for two reasons: (1) because allowing an embedded video it would make it very difficult to assess whether an offeror has circumvented the 150 technical proposal page limitation, and (2) because Section 4.3.2.1.3 states that, “Proposals shall not include links to internet web site addresses URLs or otherwise direct readers to alternate sources of information” (emphasis added). We interpret that “alternate sources of information” would include any videos, even if they are embedded in the proposal PDF, as they would bring in information that is not included in the standard format of the written proposal document.

QUESTION 25: Are offerors allowed to include publication costs such as open access charges and manuscript preparation in proposed budgets under this solicitation?

Page 7 of 8 Amendment Four (4)

The only guidance we could find regarding this was on page 40 of the solicitation, that resulting contracts should “Limit the procurement of meeting space, promotional items, printing and publications.”

RESPONSE: Generally, manuscript/publication costs are not allowable because they are not considered to be allocable to a contract unless there is a direct benefit to the Government.

QUESTION 26: While we understand from the BAA that certified pricing may be required in some cases—on Page 118, the BAA indicates that adequate price competition is likely to occur.

Given the possibility of an adequate pricing exemption, our question is whether we would need to submit certified pricing data without a separate exemption.

RESPONSE: Certified cost or pricing data should be submitted with this proposal unless a specific exception exists. Here, each proposal stands on its own and the offeror develops their own SOW, so there is no cost data to compare to between proposals.

II. RESEARCH AREA SPECIFIC QUESTIONS

1) RESEARCH AREA 001:

QUESTION 1: For our submission in response to research area 001, we are not planning to perform any clinical studies. Is a clinical synopsis still required? Most of the information that would be included in a clinical synopsis is to-be-determined pending the data that would be generated on the proposed project.

RESPONSE: If there is no intent to perform a Phase I clinical trial either in response to this BAA or to another funding mechanism, then no synopsis is required. However, if there will be a Phase I clinical trial but funded via alternative mechanisms, then a clinical synopsis will be required. In many cases, understanding the Phase I trial design will drive the amount of vaccine material to be GMP manufactured and scale up level of investigational product to guide manufacturing for the Phase I trial and beyond.

QUESTION 2: Under RA 001, should the items for the PDP as indicated in a‐h on pp. 19‐20 be incorporated into the example PDP outline, items 1‐8, on pg. 51? Or, should the items a‐h on pp.

19‐20 be addressed in separate sections from the PDP outline (items 1‐8) on pg. 51? In the PDP outline on pg. 51, do items 1‐2 refer to preliminary work (i.e., preliminary data from efficacy and animal safety studies), and do items 3‐8 refer to proposed work (including additional efficacy and animal safety studies)?

RESPONSE: The PDP should detail the specific tasks and stages to be performed with contract funding and should address all elements described in Section 3.4.1. of the BAA. Those activities defined in the PDP, which the contractor will be performing in the contract, shall be described in the SOW. Offerors shall provide detailed specifications of their requirement following the SOW outline provided in Section 4.3.2.2. Any tasks or subtasks listed in the sample SOW that are not applicable to your proposed effort should be deleted. Any tasks or subtasks specific to your proposed effort not addressed shall be added.

2) RESEARCH AREA 002:

Page 8 of 8 Amendment Four (4)

QUESTION 1: Would you please let me know if this program supports research on antibiotic potentiators?

RESPONSE: Due to the competitive nature of the BAA, the NIAID is unable to offer advice or feedback regarding a specific therapeutic candidate. Please refer to Section 3.3.2.2 for antimicrobial spectrum and priority pathogens, and Section 3.3.2.3 for additional requirements.

QUESTION 2: We have identified two natural proteins (a surfactant protein and an immunoglobulin) with fungistatic activity against A. fumigatus and Candida species, the two major opportunistic fungal pathogens, and a peptide of plant source that showed fungicidal activity against both fungal pathogens. Our preliminary data performed suggest that these natural compounds are also functional against resistant isolates of A. fumigatus and Candida species.

Based on these results, our proposal will aim at combining fungistatic and fungicidal activities of these natural compounds against resistant isolates of A. fumigatus and Candida species. Would these approaches be eligible within the Research Area 002?

RESPONSE: Due to the competitive nature of the BAA, the NIAID is unable to offer advice or feedback regarding a specific therapeutic candidate product. Please refer to Section 3.3.2.1 “Technical Objectives” and Section 3.3.2.2 “Technical Approaches” for antimicrobial spectrum, priority pathogens and details of development phases. In addition, you may refer to Section

3.3.2.3 “Additional Requirements” to determine if the candidate product has demonstrated the required evidence.

QUESTION 3: Would it be appropriate to propose completion of our base device for SARS‐ CoV‐2 while in parallel finalize development and testing of a multiplex for SV2 and influenza?

RESPONSE: The BAA states that awards will support development of tests against at least one of the targets from the list in Section 3.3.4.2 – Technical Approach, p. 18. While influenza virus is out of scope (not on that list), SARS‐CoV‐2, as a novel coronavirus, is in scope; therefore, development of a test that targets at least SARS‐CoV‐2 is considered in scope.