Amendment_2_BAA-NIAID-NIHAI201700104.pdf

Amendment No. 2 to BAA-NIAID-NIHAI201700104 “Immune Mechanisms of Protection against Mycobacterium tuberculosis Center (IMPAc-TB)”

Amendment to Solicitation No.: BAA-NIAID-NIHAI2001700104

Amendment No.: 2

Issue Date: June 7, 2018

Effective Date:

Proposal Due Date:

June 7, 2018

August 15, 2018 at 3:00 p.m. (EDT)

Issued By: Liem T. Nguyen Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane, MSC 9821 Rockville, MD 20892-9821

Point of Contact: Albert Nguyen, Contract Specialist 25T Unguyenal@niaid.nih.govU25T

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remain unchanged. Offerors must acknowledge receipt of this amendment. Failure to provide your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to the solicitation and its amendments for additional Questions & Answers.

Question 1: What is the deadline for this solicitation? It appears to be in August, but please confirm

Response 1:

Applications are due on August 15, 2018 at 3pm Eastern Time.

Question 2: Does the Presolicitation under solicitation number BAANIAIDNIHAI201700104 contain requirements similar to a current contract? If possible, please provide the current contract number. Or, is this a new requirement for the government?

Response 2: Solicitation Number BAA-NIAID-NIHAI201700104 is a new requirement.

mailto:nguyenal@niaid.nih.gov

Question 3:

Are there certain specific eligibility criteria and type of research suitable for this announcement?

Response 3: As stated in the second paragraph of Attachment 5, Research and Technical Objectives: “The overall goal of the IMPAc-TB program is to identify and characterize immune responses required to protect a host from initial Mtb infection, establishment of latent infection or progression to active TB disease. To achieve this goal, an integrated, flexible multi-disciplinary team of highly collaborative investigators will plan and conduct the required studies, including development of Standard Operating Procedures and assay harmonization to be implemented by the center’s members; in-depth immunologic analyses of tissue-specific and systemic responses against Mtb/TB in small animals, non-human primates (NHPs), and humans, including examination of host responses to BCG or novel, promising vaccine candidates (pre-and/or post-exposure candidates); collaborate with existing NIAID-supported and other TB programs; and distribute positive and negative study results, reagents and other resources within a center, between centers (if applicable), to other NIAID-supported programs, and the broader research community to facilitate the development of improved TB vaccines.” Therefore, offerors must assemble or be part of a multi-disciplinary team that can address all of the requirements described in Attachments 5 through 8 of the

BAA.

Question 4: Please expand on the NTM issue.

Response 4: Attachment 5 (Research and Technical Objectives) 3. Immunologic Analysis, item a. Human studies (Section 3a) gives examples of the types of questions that could be addressed within the main objectives of the program, which is “Provide in-depth systemic and tissue-specific immunologic analyses that provide novel insights into the immune responses required to (1) protect a host from initial Mtb infection, (2) establish a latent infection, and/or (3) progress to active TB disease”. One of the examples in Section 3a is a bullet that states: “Determine the impact of Nontuberculous mycobacteria (NTM) and/or HIV infection on immune response to Mtb infection or TB vaccines. NTMs are ubiquitous in nature and found mainly in soil and water sources. The level at which humans are exposed to NTMs varies by geographic location and decreased BCG vaccine efficacy in infants has been linked to areas of high NTM exposure. Studies to understand the impact of NTM exposure on susceptibility to Mtb infection and/or TB disease may be included as part of a proposal submitted in response to this BAA.

Question 5: Is there scientific criteria for the reviewers of these proposals?

Response 5: For the scientific criteria for review, please refer to SECTION M - EVALUATION FACTORS FOR AWARD, starting from page 85 of the solicitation.

Question 6: Is there a specific proposal format or template that must be used for this mechanism?

Response 6: There is no specific format or template for proposals. Please refer to Attachment 1, page 92 of the solicitation for instruction and formatting proposal.

Question 7: How can we access the eCPS website, as the link provided in the announcement (https://ecps.niaid.nih.gov) does not grant access?

Response 7: Access to the eCPS website can be granted by following this link: https://ecps.nih.gov.

Additional information regarding proposal submission can be found Attachment 1 – “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website”.

https://ecps.niaid.nih.gov/ https://ecps.nih.gov/

Question 8: I understand the proposal should include the non-severable initial base work (12-18 months) plus all proposed non-severable portions of work. However, I have read Attachment 8 and I do not understand how this is supposed to be organized? Should each segment get its own separate section?

Response 8: Please refer to the info/instructions included in attachment 8 to prepare your proposal. If you prefer to prepare each segment separately, you can do so, but it is not required.

Question 9: Will NIAID plan to have a webinar to help complete the application.

Response 9: NIAID will not be having a webinar to assist with complete the application. Offeror can submit questions related to the solicitation via email to the point of contact listed in the solicitation and we will provide clarification.

Question 10: Will we need to specify in detail all of our possible options after the base period with this current submission? Or will these options be solicited later, during the base period at which time we would then provide the details about the “option” program and budgets?

Response 10: Offerors must specify the details of all possible options including the base period in their original proposal.

Question 11: Please clarify if Section K – Representations, Certifications, and Other Statements of Offerors is still a required section if this information has already been provided electronically via http://www.sam.gov.

Response 11: If Representations, Certifications, and Other Statements are provided in SAM.gov, please state that in your Proposal.

Question 12: Please clarify if IRB approval is required at the time of submission, or if IRB approval can be obtained at the award stage.

Response 12: Applicants do not need to have IRB approval prior to submission of proposal. IRB approval can be obtained at the award stage (or after award depending on the timing of the human work).

Question 13: Please clarify if the project budget should be submitted as a PDF (within the Business Proposal), separate Excel file attachment, or both.

Response 13: The Project Budget should be submitted both as a separate excel file and part of the PDF business proposal.

Question 14: Please clarify if the project budget should cover only the initial 12-18 month period or if the project budget should reflect all project costs up the maximum seven years.

Response 14: The project budget should reflect all project costs up to the maximum seven years or up to the maximum number of years proposed by the offeror but not exceed seven years.

Question 15: Should we provide a small business subcontracting plan for sites to which we will issue subcontracts?

Response 15: A small business subcontracting plan is required for each proposed subcontract with an estimated cost that exceeds $700,000.

Question 16: What is the date after which NIH will no longer answer questions associated with this RFP?

Response 16: Offerors must allow a 2-week responding time for the Government to review the questions and provide answers.

http://www.sam.gov/

Question 17: My question about multi-PI applications. In the Amendment No. 1 document the following is written:

Question 6: Is a proposal with multiple PI leadership an option? Response 6: Yes, a proposal with multiple Principal Investigators (PI) is an option. Please refer to section L.2.b. Technical Proposal Instructions, item 1.b.2.

Other Investigators on page 53 of the solicitation.

However, when I went to this section on Page 52-54, there is no explicit statement of MPI. Can you please clarify this point, i.e. Instead of one Program PI/PD, can we have multiple (2-3) MPIs who will co direct the program? Can the MPIs be from different institutions?

Response 17: Please see the excerpt from page 52 of the BAA below:

‘Single Principal Investigator/Project Director List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.”

You may propose multiple investigators who will co-direct the program and they can be from different institutions.

Question 18: Sample contract grants: for the scientific/technical portions, are there any sample applications available to view?

Response 18: There is no sample application available. Please be advised that this is for a contract, not a grant. Offeror submits a proposal in response to the solicitation.

Question 19: Co-Is: It is stated that an individual can be co-investigator on more than one application. Can you confirm that this would also apply to a clinical investigator who is leading cohort studies?

Response 19: Page 53 of the BAA States: “OFFERORS 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.”

Investigators may be proposed on more than one application so long as they are not committed more than 100% of their time.

Question 20: For the small animal mouse model, I noted that "The use of relevant small animal models that go beyond commonly used laboratory mouse strains is strongly encouraged”. Do you mean that animal models OTHER than mice are strongly encouraged (e.g. rabbits, guinea pigs) or that non-traditional mouse strains are encouraged (e.g. C3hFeJ, collaborative cross etc.)? Also, is proposing traditional Balb/c or B6 and/or knockout mice in these backgrounds considered to be responsive?

Response 20: Use of traditional mouse models is responsive to the BAA. NIAID encourages the use of non-traditional mouse strains or other small animal models that may more closely represent human responses, in addition to or in place of traditional mouse models.

Question 21: Are there any restrictions on requesting funding for equipment?

Response 21: Please see the excerpt below from Page 79 & 80 of the BAA for information regarding equipment.

9. Other Administrative Data

a. Property

1. It is HHS policy that Contractors will provide all property necessary for contract performance.

Exception may be granted to provide Government property (Government-furnished or Contractor-acquired), but only when approved by the Contracting Officer. If the offeror requests that Government property be provided, other than that specified under "Government Furnished Property," below, the proposal must include a comprehensive justification addressing the following items:

a. State why the property is essential to contract performance and whether the property will be used exclusively for this contract.

b. Describe other alternatives (e.g., purchase, lease, etc.) pursued and why they were not viable options.

2. Government Property

a. A list or description of all Government property that the offeror or its subcontractors propose to use on a rent-free basis. The list shall identify the accountable contract under which the property is held and the authorization for its use (from the Contracting Officer having cognizance of the property);

b. The dates during which the property will be available for use (including the first, last, and all intervening months) and, for any property that will be used concurrently in performing two or more contracts, the amounts of the respective uses in sufficient detail to support prorating the rent;

c. The amount of rent that would otherwise be charged in accordance with FAR 52.245-9, Use and Charges; and

d. A description of the offeror's property management system, plan, and any customary commercial practices, voluntary consensus standards, or industry-leading practices and standards to be used in the offeror in managing Government property.

Question 22: If our proposal has a duration of 7 years, could we request total funding of $136.5M, at the rate of $19.5M per year?

Response 22: NIAID anticipates making one to three (1-3) awards for the entire IMPAc-TB program and providing up to $19.5 million (total direct and indirect costs combined) for all awards combined for the initial, non-severable base work, which is anticipated to last 12-18 months depending on an offeror’s technical approach and proposed milestones.

Funding levels for additional non-severable work components beyond the initial non-severable base will be dependent upon the offeror’s proposed approach.

Question 23: My foreign subcontractor does not have or use the 508 Program. Do reports prepared by foreign subcontractor have to be in compliant with Section 508?

Response 23: All reports prepared and submitted by the Prime contractor which include portion of the subcontractor’s report must be in compliance with Section 508.

Questions 24: We anticipate that we may involve partners as subcontractors in later years of the project, but their involvement is dependent on scientific results of the project and therefore may or may not materialize. What will the process be to add institutions as subcontractors later in the project that were not included in the individual application? Is it required to include all potentially foreseeable collaborators in the initial proposal, even if it is currently unclear whether they will be involved?

Response 24: In the case where work to be performed by subcontractors in later years of the project are dependent on the results of the project which may or may not materialize, the proposed technical approach and corresponding budget for this potential work should be included in the proposal as an option which may or may not be exercised.

Question 25: The budget template for the proposal is quite detailed, but expenditures on the project will be dependent on scientific results and the outcomes of go/no-go decisions. Can you provide any guidance on how to construct a budget that adheres to the budgetary guidelines but also allows for the flexibility required by the award?

Response 25: Offeror should follow instructions provided in the template and prepare the budget accordingly. Offeror should prepare a proposed budget to be consistent with the nature and complexity of the proposed research.

Question 26: Can you provide some general information about the process of making changes over the life of a contract? When a new contract year starts, what is the process for making changes from the previous year in terms of budgets and collaborators?

Response 26: Once contract is awarded and work starts, any change in terms of budgets (within the approved ceiling) and collaborators must be submitted in advance to the COR and CO for review and approval.

Question 27: We understand that this proposal involves an initial phase of 12-18 months with an option of up to 7 years in total. Should the budget be structured with one 18-month initial period and annual 12-month budget periods thereafter (with a final year of 6 months) or is another methodology preferred?

Response 27: Offerors should plan to structure the budget according to the proposed technical approach and proposed milestones. The period of performance for each segment/phase can last however long it is necessary to complete the proposed tasks for each period. The maximum period of performance for this solicitation is seven (7) years. Option periods may overlap.

Question 28: Regarding Attachment 8, Section 9, number 2: Can you please confirm whether each subcontractor will have an annual site visit or if the site visit will be at the prime contractor’s location only?

Response 28: Site visit(s) generally are held at the Prime contractor’s location. However, depending on the proposed work to be performed by a subcontractor, site visit might take place at a subcontractor’s location.

Question 29: Is the NIH planning to schedule a call for investigators to ask questions about the RFP?

Response 29: Investigators who have questions about the solicitation can submit the questions via email.

NIAID will not be conducting a call for investigators to ask questions regarding this Solicitation.

Question 30: I have a clarification question regarding page limits for the Technical proposal. Are there page limits for Sections 4, 5, 6 and 7

Response 30: Please refer to the solicitation, Attachment 1, page 2, for instruction regarding page limitation.

Question 31: On page 3 of Attachment 5, it states “Small animals (e.g., mice, guinea pig)…” Are mini-pigs considered to be a small animal model for this application?

Response 31: While offerors are required to plan and conduct comparative analyses of tissue-specific and systemic immune responses against Mtb/TB in small animals (e.g, mice and guinea pigs), non-human primates (NHPs), and humans, studies in minipigs or other relevant animal models also are permitted. The selection and use of each animal model must be well justified and include a description of the methods that will be used to integrate study results obtained from all animal models and human studies.

Question 32: Can you confirm whether or not recent presentations about this BAA at recent meetings are being posted on the FedBizOpps.gov website?

Response 32: NIAID does not have any presentations regarding this BAA available.

Question 33: Can you please advise whether a multi-PI structure is allowable for this proposal/award?

Response 33: Yes, a proposal with multiple Principal Investigators (PI) is an option. Please refer to section L.2.b. Technical Proposal Instructions, item 1.b.2. Other Investigators on page 53 of the solicitation.

Please see the excerpt from page 52 of the BAA below:

‘Single Principal Investigator/Project Director List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.”

Question 34: Does the 150-page limit for the Technical Proposal includes references?

Response 34: Anything other than the title page, back page, table of contents and section dividers will be included as part of the total page count of the Technical Proposal. Please see page 93 of the BAA:

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 150 pages (inclusive of all attachments and appendices).

2. Total page count does not include: Title and Back Page; Table of Contents; and Section Dividers that do not contain information other than title of Section. CVs shall not exceed three pages.

3. Pages in excess of this limitation will be removed from the proposal and will not be considered.

Question 35: In regards to RFP BAA-NIAID-NIHAI201700104, is there a page limit to the Business Proposal section?

Response: 35 The Business proposal section does not have a page limitation.

Question 36: Is a Small Business Subcontracting Plan is required for a Foreign subcontractor with a budget over $750,000?

Response 36: If the contractor is located outside of the U.S. and its outlying areas, and the services provided by the subcontractor performed outside of the U.S. and its outlying areas, the SBSP is not required. See FAR 19.702 Statutory Requirements, paragraph (b)(3).

(b) Subcontracting plans (see subparagraphs (a)(1) and (2) of this section) are not required --

(3) For contracts or contract modifications that will be performed entirely outside of the United States and its outlying areas; or

Question 37: Is an inflation index allowed for budgeting purposes? If so, what is the inflation percentage to be used?

Response 37: An escalation factor is allowable. The rate used must be realistic based on the Consumer Price Index. If an escalation rate is used for labor, it must be consistent with your organizations policy for providing salary increases.