Amendment 0002 - signed.pdf

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AMENDMENT #0002

RFP- NIHAI75N93023R00003

“PRE-CLINICAL MODELS OF INFECTIOUS DISEASES”

Amendment Number: 0002

This Amendment provides a lists questions submitted by interested parties and the responses provided by the National Institute of Allergy and Infectious Diseases (NIAID).

AMENDMENT TWO (0002)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID)

Office of Acquisitions, MSC 9821 5601 Fishers Lane Rockville, MD 20852

Solicitation Number: NIHAI75N93023R00003

Date of Solicitation Issuance: February 15, 2023

Date of Amendment No.0001 Issuance: March 10, 2023

Date of Amendment No. 0002 Issuance: March 24, 2023

Number of Pages: 8 pages

NIAID Point of Contact: PRIMARY:

Ignacio Reyes, Contracting Officer Email: ignacio.reyes@nih.gov Phone: 301-435-7574

SECONDARY:

Charles H. Jackson, Jr. Contracting Officer, Team Lead Email: Charles.Jackson@nih.gov Phone: 240-669-5175

Offerors must acknowledge receipt of the posting of Amendment #0002, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals remains unchanged.

mailto:ignacio.reyes@nih.gov

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THE FOLLOWING PAGES PROVIDE ANSWERS AND STATEMENTS CONCERNING A

NUMBER OF INQUIRIES WE HAVE RECEIVED FOR THE ABOVE CITED SOLICITATION:

Question

No.

Question / Response

1 Question:. Is each Task area a separate submission or combined into one volume\submission?

Response: Each task area is a separate submission.

2 Question: In terms of the budget, how to divide up the effort for key personnel for the base contract in the absence of any awarded Task Orders? From my understanding of the contract, we provide a budget that gives the NIH an idea of the cost associate with a given task area. What is unclear is whether key personnel effort is provided during the ramp on process of contractors and prior to being awarded a task order.

Response: The budget for the proposal should be correspond to the work proposed for the Sample Task Order and the effort for key personnel performing that work. Once a task order is awarded, the direct labor costs are charged to the appropriate awarded task order and not to the base contract. The base contract award is only for the guaranteed minimum amount of funds.

3 Question: For subcontractors, do we need to provide a letter of intent? What is the extent of paperwork required for subcontractors?

Response: The subcontractor does not have to provide a letter of intent. The purpose of the letter of intent is to provide the Scientific review office a projected number of proposals expected from interested parties for planning technical review meeting(s).

Additionally, see Section 13 on page 102 of the solicitation:

13. Subcontractors

If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

a. Willingness to perform as a subcontractor for specific duties (list duties).

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A complete cost proposal in the same format as the offeror's cost proposal.

4 Question: Is there a template for the CVs/[Biosketch]?

Response: See the attached link: https://grants.nih.gov/grants/forms/biosketch.htm https://grants.nih.gov/grants/forms/biosketch.htm

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5 Question: For Task area C: Is the use of human organoids\organs-on-a-chip responsive to the RFP? Can [offerors] propose to use human samples to generate organoids for cross-comparing infections between human and animal species?

Response: The use of human organoid/organ-on-a-chip models is responsive to Task Area C and the use of de-identified human samples to generate organoids is within the scope of work.

6 Question: Is it the intention that the initial response to solicitation will include only a budget for a “base contract” and that would include only a minimum amount needed in order to have the requisite facilities/services available?

a. When specific [Task Order Request For Proposal] (TORFP) are [issued], the subcontractor would propose specific study scope of work and part of that response to TORFP includes a business proposal/budget for that specific study and would only include costs specific to that particular TORFP?

b. And therefore over the life of the contract award, there may be multiple TORFP each with their own agreed upon budget proposal based on scope of work, but again this is separate from the base contract business proposal that is submitted with this current response?

c. It sounds like that is the intention to have a [base] budget and then over the life of the contract specific study budgets that are in addition to [base] budget, but want to be clear about it as that is obviously not a common funding method.

Response: No, the base contract awards are only for the guaranteed minimum amount.

a. Responses to future Task Order solicitations will require technical and business proposals as well as a budget that corresponds with the requirements.

b. The awarded IDIQ base contracts under this solicitation will establish a qualified pool of Contractors for Task Areas A-D. Based on the Government’s bona fide need and funds availability, it is anticipated that Contractors which received awards will have the opportunity to respond to Task Order solicitations within their task area over the course of the seven-year ordering period. As noted, Contractors receiving awards will respond to future Task Order solicitation and will be required to provide a technical and business proposal as well as a budget for the work to be performed.

c. There is no budget associated with the Base IDIQ contracts. As mentioned, the Base IDIQ contracts establish the qualified pool of Contractors. Each Task Order solicitation will carry its own funding.

7 Question: For [Task] Area C, the following specific questions related to each listed service:

a. Would refinement of an existing model include modification of a non-animal model (organ-on-chip) that currently operates in BSL-3 to enable utilization in a BSL-4?

b. Can NIAID provide candidate countermeasures for evaluation or is this the responsibility of the performer?

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c. Does NIAID consider validation of animal replacement models to include benchmarking between laboratory systems and human clinical data, or is benchmarking between animal data and animal cell culture systems also required?

Response:

a. For the purposes of this solicitation model refinement is defined as:

a systematic effort to improve the performance of an existing animal model that reproduces a clinical syndrome caused by an infectious agent; to adapt an existing animal model that reproduces a clinical syndrome caused by one infectious agent to a different, but related, infectious agent; to adapt an existing animal model to optimize its ability to support product screening or evaluation following challenge with the infectious agent.

It is up to the Offeror’s judgment to decide if the proposed modification would improve model performance, adapt an existing model to another infectious agent, or optimize the model for product screening.

b. For the purposes of the Sample Task Order, the performer/offeror would be responsible for selecting and procuring the countermeasure for the proof-of-concept study.

However, after the Base Contracts are awarded for the Task Areas, Task Order solicitations would identify the candidate countermeasures to be provided by a NIAID-designated third parties. Future Task Area, Task Order solicitations will describe what is to be provided by the Government and what is to be provided by the Contractor.

c. Future task orders may require benchmarking between an animal replacement model, human clinical data and/or animal data depending on the Government’s established bona fide need. At this time, the Government’s future bona fide needs are not known.

8 Question: General Programmatic Questions:

a. Clarify the process for responding to the specific proposal calls (TORFP)? Will there be multiple TORFPs or a single call?

b. Would datasets or defined compound screens qualify as quantifiable deliverables for such an IDIQ contract?

Response:

a. Once Base Contract awards are made, it is anticipated that multiple Task Order solicitations may be issued throughout the seven-year ordering period. The number of Task Order solicitations will depend on the Government’s bona fide need and will be contingent on the availability of funds. Task Order solicitations will be communicated electronically to the contractors to the appropriate Task Area pools well in advance of the submission date.

b. Deliverables typical for Task Order awards include, but are not limited to: progress reports, meeting minutes, study reports, study protocols, and raw data.

9 Question: Do you have a network of potential applicants who are looking to work with industry partners?

Response: There is not an established network of potential investigators associated with this solicitation. The Government receives requests for the services from investigators in

RFP- NIHAI75N93023R00003 Page 5 of 8 academia, industry, Government, etc. and the services are provided by the Contractors in the appropriate IDIQ pools.

10 Question: What is the due date for the letter of intent? Also, is the template on the attachments entitled “Proposal Intent Response Form” supposed to be used for this RFP?

Response: No due date for the letter of intent. However, if you plan on submitting a proposal, submit the letter before the proposal due date. All documents attached are for this

RFP.

11 Question: RFP Article B.4 Page 9 Ramp On Of Contractors Will the Government use the Ramp On Of Contractors to allow contractors who are awarded a Task Area(s) to submit ramp on proposals in response to a ramp on solicitation for Task Areas other than originally proposed and awarded (ie add an awarded Task Area(s)?

Response: A Ramp On solicitation may be issued at the Contracting Officer’s discretion and if it is beneficial to the Government. Should this occur, an Offeror may submit a proposal responding to a Task Area which you have not received an award.

12 Question: Sample Task Order A - Sample Task Order B.

Could the government please clarify use of the word "therapeutic" in Section II of Sample Task Order A. Does this imply that the test article to be evaluated must be an antibacterial, antiviral, antifungal, etc. compound administered post-challenge following disease confirmation (i.e. in a therapeutic model)? Or is the term being used interchangeably with test article such that the proposed candidate product could be a vaccine candidate or pre-exposure prophylactic administered to prevent disease (as stated in Section I under Scope)?

Response: The candidate countermeasure proposed to be tested under any of the Sample Task Orders may be a vaccine or therapeutic delivered either pre- or post-exposure.

13 Question: Attachment 2, Creating and Naming Files Ref. Text. 5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

If Offeror is submitting on more than One (1) task area (A through D), should Offeror add "Task Area XX" in the file naming convention for 'each' task area proposal (inclusive of three documents each noted in instructions), as demonstrated below

Examples:

Technical Proposal: XYZ Company_TASK AREA XX_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_TASK AREA XX_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_TASK AREA XX_NIHAI2012001_Business.xlsx

Response: The proposed naming convention would be acceptable to the Government as long as proposals for each Task Area A-D are submitted separately in eCPS.

14 Question: [On] RFP Pgs. 77 and 102; Past Performance / Performance History

Please clarify that Offeror should list ONLY 3 total contracts completed within the last years OR currently in process and not 3 contracts "completed" AND 3 contracts "currently in process" for a total of six (6) contracts.

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Response: The Offeror should list only 3 contracts. These may be contracts that are completed, contracts that are in progress or a combination of the two as long as they are similar in nature to the solicitation work scope.

15 Question: Attachment 5 Attachment 5 of the solicitation outlines the six sections of the technical proposal and provides “suggested" page maximums for each section. Is NIAID amenable to offerors rebalancing the distribution of pages in each section as long as the total proposal page count does not exceed the 100 page limit?

Response: Page maximums for the different sections are suggestions. As long at the Technical Proposal does not exceed 100 pages, the number of pages used for each section is at the discretion of the Offeror.

16 Question: Given the time required to identify and engage potential subcontractors and subject matter experts to address multiple Task Areas, will the government open an additional Q/A period in early April to allow for additional questions from proposing organizations?

Response: Potential Offerors had a month from the issue date of the solicitation to develop and submit questions. Currently, the government does not plan to issue another amendment.

If offerors’ proposals are determined, by the scientific reviewers, to be technically acceptable and are included in the competitive range by the Contracting Officer, the government may invite those offerors in to conduct negotiations. Contract awardees will receive task order solicitations in their awarded area(s) and have the opportunity to compete by submitting technical and business proposals which includes subcontracting details.

17 Question: What is the due date for the letter of intent?

Response: To assist with planning, submit your Proposal Intent Response Form on April 4, 2023, by 3:00 PM EST. The intent notice is not a prerequisite for submission of Task area proposals.

18 Question: Are there any formal steps (e.g. Letter of Intent) that need to be completed/submitted prior to the 5/4/23 deadline?

Response: No formal steps. See question #17 above.

19 Question: When describing offerings within the technical proposal, would reviewers prefer highly-detailed offerings relevant to a specific disease (e.g. influenza B6 mouse model) or is it more informative and constructive to provide generalized offerings (e.g.

respiratory virus mouse models) that would included, for example, influenza and coronavirus?

Response: For the Technical Overview it would be beneficial to specify the infection models (pathogen and model species/strain or model tissue system) that the Offeror can provide. For the Sample Task Order, sufficient experimental detail should be provided to assist the reviewers in understanding the Offeror’s approach to model development/refinement and use.

20 Question: Do we need to create a master data document for individual technical documents (e.g. Appendix 1 for TB, Appendix 2 for coronavirus, etc.) or an individual technical portfolio that will have their own supporting data files?

Response: All models, identified within a Task Area, can be presented briefly in the Technical Overview and one infection model should be proposed for the Sample Task Order.

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21 Question: Clarify requirements for identifying personnel? For example, is it acceptable to list generic ‘research technicians’ and only identify key personnel (i.e. PIs, Program Managers, etc.)?

Response: The Technical Proposal Instructions state:

Describe the experience, training, expertise and qualifications, level of effort and project roles, for all proposed key scientific personnel and technical staff.

Other key scientific personnel and technical staff should describe expertise in infectious disease research pertinent to human disease (bacteriology, virology, parasitology, and toxicology),veterinary science, product evaluation, regulatory science, quality control/assurance.

As relevant, provide documentation of training related to select agent use as well as training in BSL-3 or BSL-4 laboratory procedures.

Offerors must provide a description of the experience, training, expertise, qualifications, level of effort, and role for the key personnel that are proposed to be involved with the contract. It is preferable to provide this information for known, named professional and technical staff, however the Government is aware that there are situations where staff who will be assigned to a future project are not known. Therefore, for as-yet unnamed staff, the Offeror should include a description of the experience, qualifications, role, etc.

corresponding to the position.

22 Question: What level of granularity of the proposed budget(s) is required for the business proposal and with the understanding that many projects constitute custom work flows?

Response: The budget should correspond to the requirements of the Sample Task order and should have sufficient detail to determine if the proposed costs are appropriate and allowable for the work proposed.

23 Question: Is the preference to have one single consolidated business plan/ [proposal] that is reflective of all offerings or individual plans specific to each offering?

Response: The Offeror should provide one business proposal for each Task Area A-D to which they choose to respond.

24 Question: Test Article for Sample Task Orders A and B:

Should [the Test Article] be a commercially available licensed drug/vaccine?

Response: The test article is not required to be approved or licensed but would be a countermeasure that is appropriate to test the validity of the newly established or refined model in a proof-of-concept study.

25 Question: Cost assumptions specify BSL-2 level for Task Order A and BSL-3 level for Task Order B. Question: Can you confirm that [offerors] are expected to price a BSL-3 study for Task Area B and BSL-2 study for Task Area A?

Response: Offerors should propose the containment level that is appropriate for the selected pathogen and should provide proper certifications and assurances that work at that containment level is permitted.

26 Question: [Offerors] are asked to “provide information relevant to document individual training, experience, qualifications, and expertise for proposed scientific and technical personnel associated with the sample task order. (CVs should not be included in the sample task order.)” Question: Could we get clarification regarding the type of information, when not in a CV, that is being requested. Would a few paragraphs, describing each key staff member be acceptable?

Response: For the Sample Task Orders, Offerors should provide a brief description of the key personnel in terms of expertise, experience, current duties, and proposed role in the

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Sample Task Order. In addition, the key personnel that are proposed to be involved with the base contract(s) (in each awarded Task Area) should have CVs provided. (See Attachment 5 – Section 4)

27 Question: In Sample Task Order A, it says to pick one infectious agent of the offeror's choice. Per attachment 7, we are to budget for BSL-2 containment. If the challenge agent is M. tb, it requires BSL-3 containment since any vaccine study will involve challenge with M. tb. Does this mean we need to pick an infectious agent that requires BSL-2 containment for sample task order A? Or, for purposes of the Sample Task Order A proposal, should we assume BSL-2 containment even for M. tb?

Response: Offerors should propose the containment level that is appropriate for the selected pathogen and should provide proper certifications and assurances that work at that containment level is permitted.

28 Question: Page 102 of the Solicitation states that Subcontractors should submit “A complete cost proposal in the same format as the offeror's cost proposal.” We would like to know which of the following documents should be included with any subcontract cost proposal:

a. Qualifications of the Offeror

b. Certificate of current cost/pricing data

c. Small Business Subcontracting Plan (if over the $ threshold)

d. Past Performance Information Response: All required components of the prime Offeror’s Cost Proposal should be included in the Subcontractor’s Cost Proposal

29 Question: In regard to “Task Area C: Animal Replacement and Non-traditional Animal Models of Infectious Diseases,” are the following models covered:

• Hollow Fiber Infection Model

• Spheroids/organoids Infection and pharmacokinetics Model

• Microfluidics infections Model Response: These models are within the scope of work.

30 Question: Please clarify the total page count for each Technical Proposal.

Response: The total page count for the Technical Proposal is 100 pages.

31 Question: Please confirm the page limit for CVs.

Response: The limit for each CV is 3 pages.