Amendment 1 RFP 75N93026R00008.pdf

AMENDMENT #1 RFP No. 75N93026R00008 1

Amendment No. 1 RFP No. 75N93026R00008

“Immune Mechanisms of Protection Against Mycobacterium tuberculosis Center (IMPAc-TB)”

Solicitation Number: 75N93026R00008

Amendment Number: One (1)

Amendment Issue Date: July 7, 2026

Proposal Due Date/Time: September 1, 2026 at 3:00 PM, EST (Unchanged)

Issued By: Christopher Ray

Contracting Officer Research & Development and Professional Services, Division A

OALM/OD/NIH/DHHS

6701 Rockledge Drive Bethesda, Maryland 20817-7786

Points of Contact: PRIMARY chris.ray@nih.gov Chris Ray, Contracting Officer Phone: 240.627.3365

SECONDARY

cornorj@niaid.nih.gov Robert Corno, Contracting Officer Phone: 240.669.5151

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement 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.

The purpose of this Amendment is to provide responses to questions from potential offerors, regarding the solicitation.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

mailto:chris.ray@nih.gov mailto:cornorj@niaid.nih.gov

AMENDMENT #1 RFP No. 75N93026R00008 2

Question 1 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 to Question 1 Yes, please, complete and INCLUDE as part of your BUSINESS PROPOSAL: SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS which is included as an Attachment in Section J-LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS of this solicitation.

Question 2 Please clarify if Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) approval is required at the time of submission, or if IRB and IACUC approval can be obtained at the award stage.

Response to Question 2 The Technical Proposal should document methods for obtaining and maintaining Institutional Animal Care and Use Committee (IACUC) approval for animal work, IRB approval for the use of human samples and authorization to work with select agents, if applicable for the prime Contractor and all subcontractors (if applicable).

When possible, the Offeror must also certify the IRB's review and approval of the research. If the Offeror cannot obtain this certification by the time of proposal submission, they must include an explanation in their proposal.

Under governing policy, federal funds administered by the Public Health Service (PHS) shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW), of an animal welfare assurance that complies with the PHS policy on humane care and use of laboratory animals and/or a valid Institutional Animal Care and Use Committee (IACUC) approval. This restriction applies to all performance sites (e.g. Collaborating Institutions, Subcontractors, Subgrantees) without OLAW-approved assurances, whether domestic or foreign.

Question 3 Please clarify if we can use our own preferred format for the Curriculum Vitae (CV) required for all scientific personnel (BAA p.141); or if we are required to use a specific format.

Response to Question 3 Please refer to Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, Section II., for formatting and page limitations.

You may use your own format, however, please adhere to page limitations and formatting requirements.

Question 4 Please clarify if subcontractors over $900,000 should submit their small business subcontracting plan individually to the HHS SBCX system or if the prime applicant organization submits a small business subcontracting plan on behalf of the subcontractor.

http://www.sam.gov/

AMENDMENT #1 RFP No. 75N93026R00008 3

Response to Question 4 The Offeror (Prime) is required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled 'Small Business Subcontracting Plan,' RFO Clause No. 52.219- 9, incorporated herein by reference in the Solicitation.

The Offeror (Prime) is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov.

In reference to subcontractors, the Offeror’s small business subcontracting plan must provide assurances that all subcontracts the contract clause 'Utilization of Small Business Concerns.' Assure that all subcontractors, other than small businesses, in excess of $900,000 adopt a plan similar to the plan agreed upon by the offeror (subcontractor’s plans should not be submitted to SBCX).

Question 5 Please clarify what information we should provide for Attachment 19 (Wage Rate Determination).

Response to Question 5 RFO Clause 52.222-41, Service Contract Labor Standards (Aug 2018) is incorporated by reference, which, in part, requires contractors and subcontractors pay covered service employees at least the minimum wages and fringe benefits specified in the applicable Department of Labor wage determination attached to the contract (Attachment 19).

Proposed pay rates for applicable positions must conform to the Wage Rate Determination (Attachment 19).

Note: Wage Rate Determinations are based on locality. Please refer to SAM.gov to find the Wage Rate Determination that pertains to your locality.

Question 6 Is there a preferred proposed starting date that we should be targeting for the purpose of this proposal?

Response to Question 6 It is anticipated that two to three awards will be made from this solicitation and that the awards will be made on/about September 29, 2027. The period of performance will coincide with the award date.

Question 7 Subcontracting Plan Submission needs to be submitted electronically using the HHS’ Small Business Customer Experience (SBCX) system (pg. 31) – does this apply to the subawards that are part of a collaborative program involving multiple sites under a Co-ordinating Center? Are these considered subcontracts under the Prime Contractor and as such should they be included in an electronic submission through the SBCX system?

Response to Question 7 Please refer to Question 4 and Response to Question 4.

https://osdbu.hhs.gov/

AMENDMENT #1 RFP No. 75N93026R00008 4

Question 8 Which business proposal excel file should be used as the template for the budget proposal. pg.

56 references Attachment 16, which has a link to a file named “buscntrctprpslsprdsht08- 2014_508.xls” while Attachment 1 on pg. 119 links to a file named “spshexcl_dec2012).

Response to Question 8 Since both forms were listed in the solicitation, both are acceptable to use to help you prepare your cost proposal. However, buscntrctprpslsprdsht08-2014_508.xls at link:

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx provides the most recent version of the form.

Question 9 Certification Regarding Tax Matters, FAR 52.209-12 (pg. 71): Does the Offeror need to include a document certifying the statements listed under Section L2.a.14(b)? Are there any additional documents that need to be included in addition to certifying the statements listed?

Response to Question 9 Please provide a document certifying the statements listed under Article L.2.a.14(b). No additional documentation is required.

Question 10 Electronic and Information Technology Accessibility Notice (pg. 72-73): Does the Offeror need to complete HHS Section 508 Product Assessment Template?

Response to Question 10 Please provide a document certifying the statements listed under Article L.2.a.14(b). No additional documentation is required.

Question 11 Sharing of Model Organisms for Biomedical Research (pg. 97) – what determines the materials/model organisms to which this policy applies? If the proposal does not include the generation of any novel model organisms, do we need to include a statement in the technical proposal to document the absence of any notable model organisms being developed under this proposal?

Response to Question 11 Organisms include but are not limited to: mammalian models such as the mouse and rat, and non-mammalian models, such as budding yeast, social amoebae, round worm, fruit fly, zebra fish, and frog. Research resources to be shared include genetically modified or mutant organisms, sperm, embryos, protocols for genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains.

Offerors must include in their technical proposal a description of a specific plan for sharing and distributing unique, model organism research resources generated using NIH funding so that other researchers can benefit from these resources, or provide appropriate reasons why such sharing is restricted or not possible.

Question 12 https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

AMENDMENT #1 RFP No. 75N93026R00008 5

Basic Cost/Price Information (pg. 98) – is there a specific format that should be used to supply this information? Can we use the level of detail and format provided in the Summary Tab of the business proposal excel (either buscntrctprpslsprdsht08-2014_508.xls or spshexcl_dec2012)?

Response to Question 12 While there is no specific format for providing the Basic Cost/Price Information, please refer to Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, Section I.B.2. and I.B.3. for the format for the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” which must be included with the proposal submission.

As stated in Question 8, since both forms were listed in the solicitation, both are acceptable to use to help you prepare your cost proposal. However, buscntrctprpslsprdsht08-2014_508.xls at link: https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08- 2014_508.xlsx provides the most recent version of the form.

Question 13 Can the budget include an annual cost escalation rate for market-based items such as flights and other travel-related costs for Years 2-5 of the proposal, similar to the inflation rate that is used for adjusting the base salary of personnel?

Response to Question 13 Yes.

Question 14 Is there Certified Cost Data that should be used under this proposal?

Response to Question 14 After receipt of proposals, the determination will be made of whether Certified Cost or Pricing Data will be used as needed to determine fair and reasonable price.

Question 15 Is there Certified Cost Data that should be used under this proposal?

Response to Question 15 After receipt of proposals, the determination will be made of whether Certified Cost or Pricing Data will be needed to determine fair and reasonable price.

Question 16 Other Pricing Data (pg. 101) - does this need to be formatted as described in Table 15-1 of FAR 15.408?

Response to Question 16 Yes.

Question 17 Mentor-Protégé Program (pg. 105): if this doesn’t apply to us, does the Offeror need to make a statement to address this or can we not include any documentation regarding that program?

Response to Question 17

AMENDMENT #1 RFP No. 75N93026R00008 6

If not applicable to the Offeror, nothing is required.

Question 18 Formatting and Page Limitations (pg. 120; Attachment 1). Do biosketches/CVs also require 1 inch margins? Do all pages in the technical and business proposals need to be numbered, including pages that separate sections and do not count towards the page limit of the technical proposal?

Response to Question 18 All pages of the proposal, including biosketches and CVs, should adhere to the formatting requirements found in Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

These pages do not have to be numbered.

Question 19 300k for cross collaboration studies (pg. 146; Attachment 8) – is this a total amount, including any indirects that are incurred under the approved proposals for cross-collaboration? Under which category of spending should this be budgeted under the prime contract?

Response to Question 19 To facilitate cross-contract collaborative studies and activities, each Contractor will propose a line item in their individual budget of $300,000/year in total costs in years two through five of the contracts.

Ideally, these costs can be categorized under ‘Subcontract Costs’, unless the Offeror deems an alternative category to be more applicable.

Question 20 Travel to Scientific Meetings (pg. 147; Attachment 8) - must the budget be limited to a maximum of 3 contract staff to attend a scientific meeting?

Response to Question 20 Yes. The budget should be limited to a maximum of 3 contract staff to attend one scientific meeting per contract year.

Question 21 Travel - is it allowable to budget for in-person internal scientific integration and program co-ordination meetings?

Response to Question 21 No. The travel represented in the business proposal should be limited to the travel requested by the Government.

Question 22

AMENDMENT #1 RFP No. 75N93026R00008 7

Annual Site Visits (pg. 147; Attachment 8) – the instructions note that we should assume at least two one-day site visits for the life of the contract. Please clarify if we should budget for two site visits per year for the life of the contract, or two site visits in total across the life of the contract? Is there a maximum number of contract travelers that we should include in the budget for each site visit?

Response to Question 22 Please assume two site visits in total across the life of the contract. There is NO maximum number of contract travelers that can be included in the budget for site visits.

Question 23 For work in our proposal that requires foreign subcontractors based on the scientific aims proposed, is there any additional documentation required and if so, where in the submission should that be included.

Response to Question 23 Foreign subcontractors do not have to submit representations and certifications or additional documentation.

Question 24 OPTIONS (pg. 147; Attachment 8) – is it sufficient to provide the detailed budgeted cost for each Option Year in the same tables where the Base Year budget is provided? In addition to showing the separate budgets for each of the Option Years, do we need to provide separate justification of the costs if they are the same types of costs proposed in the Base Year., i.e. will the same cost or price support provided in Section 2 and 3 of the Business proposal need to be repeated in Section 4 of the proposal, or is it adequate to refer to the cost support provided in Sections 2 and 3?

Response to Question 24 A single Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet can be used to provide costs for all years, Base and Option Years. Only one justification is required for costs that occur in multiple option years.

Question 25 Section K (pg. 148 – 159; Attachment 9) – this is located at the end of the BAA solicitation. Is there an editable version that is available, or should we extract these pages from the solicitation PDF and write over the PDF?

Response to Question 25 Please extract and write over or otherwise provide the REPRESENTATION, CERTIFICATIONS and OTHER STATEMENTS OF BIDDERS.

Question 26 Tax Identification Number and CAGE code (pg. 148; Attachment 9) – As an institution that has an active Federal Government contracts registration in the System for Award Management and will be submitting all relevant UEI information and EIN (on the cover page of the proposal as requested elsewhere), do we need to complete sections (c) and (d) under Section K (TIN and CAGE Code)?

Response to Question 26

AMENDMENT #1 RFP No. 75N93026R00008 8

No. Completion of paragraphs (c) and (d) of this provision at FAR Provision 52.204-90 (Deviation) (RFO Aug 2025) is applicable when the Offeror will NOT have an active Federal Government contracts registration in the System for Award Management (https://www.sam.gov) when submitting its offer.

Question 27 What is the preferred format for the biosketch/CV? Is use of SciENcv required?

Response to Question 27 All pages of the proposal, including biosketches and CVs, should adhere to the formatting requirements found in Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

Use of SciENcv is not mandatory.

Question 28 Are foreign sub sites allowed? If so, how would foreign sub sites be funded and how should we include them in the proposal?

Response to Question 28 There are no restrictions on foreign contractors (Prime and/or Subcontractors) submitting proposals in response to this solicitation.

Foreign subcontractors are funded in the same manner as any other subcontractor, and they should be included in your proposal using the same procedures and requirements applicable to all subcontractors.

END OF AMENDMENT NO. 1, RFP No. 75N93026R00008