Amendment 2 RFP 75N96025R00004 Questions and Answers.pdf

(x)

75N96025R00004 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

NICHD

Bethesda, MD 20892-7511 National Institute of Child Health National Institutes of Health

09/17/20250002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/17/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The due date for proposals in response to this solicitation is hereby extended to on or before Friday, December 19, 2025, at 4:30 PM EST to allow sufficient time for offerors to review the list of Questions and Answers attached to this RFP Amendment 2 document and incorporate the information provided herein in proposals.

Please note there is a REVISED ATTACHMENT 11 Budget Template (Excel) document provided with this solicitation amendment to correct spreadsheet formula inconsistencies and errors discovered in the original ATTACHMENT 11. Offerors should utilize this REVISED ATTACHMENT

11 in submitting their proposal budget.

Any documents previously submitted to the NIH electronic Contract Proposal Receipt System

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

JASON S. WILLIAMS

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 9

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75N96025R00004/0002

(eCPS) will be automatically overwritten when submitting like-titled replacement documents up until the due date and time indicated.

Period of Performance: 06/01/2026 to 05/31/2027

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

AMENDMENT 2

RFP 75N96025R00004

AS OF THE EFFECTIVE DATE OF THIS AMENDMENT THE FOLLOWING ITEMS ARE ADDED

AND/OR REVISED:

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.3. LEVEL OF EFFORT – Paragraph a. is amended to read as follows:

a. During the period of performance of this contract, the Contractor shall provide TBD* direct labor hours. The labor hours exclude vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

[Reference Amendment 2 Questions and Answers attachment, question 4]

SECTION J – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

As referenced in RFP Section L.3.1.B., page 75, a Technical Proposal Cost Summary attachment is added via this RFP Amendment 2 at ATTACHMENT 17. Please complete and provide as part of your Technical Proposal (does not contain pricing data related to individual salary information, indirect cost rates or amounts, fee amounts and total costs).

ATTACHMENT 17 – TECHNICAL PROPOSAL COST SUMMARY

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

Please note this is separate from, and in addition to, the Budget Proposal Template (ATTACHMENT 11).

[Reference Amendment 2 Questions and Answers attachment, question 6 and related question 9]

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS:

ARTICLE L.1. GENERAL –

Item o., below, is hereby added [page 74 of RFP – Reference Amendment 2 Questions and Answers attachment, question 2.]

o. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

2. Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

I. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

II. Accordingly, any offeror responding to this solicitation must comply with established

HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at https://www.access-boards.gov/ict.html.

III. The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions.

The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document--in detail--whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

IV. Respondents to this solicitation must identify any exception to Section 508 requirements.

If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

The "HHS Section 508 Product Assessment Template" is included in SECTION J - List of Attachments, of this solicitation.

ARTICLE L.4.A. BUSINESS PROPOSAL

The following language is hereby added for clarity:

Proposals consist of three parts: Technical Proposal, Business Proposal and the Excel Business Proposal Budget

(ATTACHMENT 11).

http://www.hhs.gov/web/508 https://www.access-boards.gov/ict.html http://www.hhs.gov/web/508

The Business Proposal document is separate from the Excel Business Proposal Budget document and shall contain supporting narrative, itemized cost breakdowns and cost substantiation data to support and explain the costs contained in the ATTACHMENT 11 Business Proposal Template fields.

In the Business Proposal document, for cost evaluation purposes, please provide an itemized list of personnel/titles/hours/annual salary for the Professional and Technical Staff to support the figures in the spreadsheet for each of the Research Outline Tabs, Website Maintenance, Training and Expert Group Tabs contained in the Budget. As an appendix, please also provide payroll slips or other supporting information to substantiate salaries for all proposed personnel as part of the Business Proposal document.

In the Business Proposal document, please also provide an itemized list of any Other Direct Costs and Materials and Supplies (identify items and quantities and provide supporting cost substantiation such as vendor quotes, catalog pricing info, etc.) to support the cost figures for each of the applicable Tabs contained in the ATTACHMENT 11 Business Proposal Template.

Subcontract cost information should be presented in the same level of detail as for the prime contractor.

Section L.4.A.1.

As of the effective date of this RFP Amendment 2, paragraph q., below, is hereby added [page 83 of RFP]

q. Data Other than Certified Cost or Pricing Data

1. Data submitted shall be sufficient to permit the Contracting Officer and authorized representatives to determine price reasonableness or cost realism, e.g., data to support an analysis of material costs (when sufficient data on labor and overhead rates is already available), or data on prices and quantities at which the offeror has previously sold the same or similar items.

Data submitted must support the price proposed. The offeror shall include sufficient detail or cross references to clearly establish the relationship of the data provided to the price proposed. The offeror shall support any data provided with explanations or supporting rationale, as needed, to permit the Contracting Officer and authorized representative to evaluate the documentation.

Data may be in the offeror’s own format.

2. The data submitted shall be at the level of detail described below.

a. Direct Labor

Provide a time-phased (e.g., monthly, quarterly, etc.) breakdown of labor hours, rates, and cost by appropriate category. Key personnel will be separately estimated as above and identified. Give the basis for the estimates in each case.

b. Materials

Provide a consolidated price summary of individual material quantities included in the various tasks, orders, or contract line items being proposed and the basis for pricing (vendor quotes, invoice prices, etc.).

c. Subcontracted Items

Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.

d. Raw Materials

Consists of material in a form or state that requires further processing. Provide priced quantities of items required for the proposal.

e. Purchased Parts

Includes material items not covered above. Provide priced quantities of items required for the proposal.

f. Fringe Benefits

Show fringe benefits as a separate line item. Include the rate(s) and/or method of calculating fringe benefits. Provide a copy of your fringe benefit rate or institutional guidelines.

g. Indirect Costs

Indicate how offeror has computed and applied offeror's indirect costs, including cost breakdowns, and provide a basis for evaluating the reasonableness of proposed rates. Indicate the rates used and provide an appropriate explanation. Where a rate agreement exists, provide a copy.

h. Special Equipment

If a direct charge, list any equipment in accordance Section L.4.a.1. paragraph

h. Government Property contained in this solicitation.

i. Travel

Provide the cost of travel including destination, duration, purpose, per diem, transportation, and the basis for pricing.

j. Other Costs

List all other costs not otherwise included in the categories described above (e.g., computer services, consultant services) and provide basis for pricing.

SECTION M – EVALUATION FACTORS FOR AWARD

ARTICLE M.1 BASIS FOR AWARD

As of the effective date of this RFP Amendment 2, paragraph 5. Is hereby amended to read as follows:

5. Selection of an offeror for contract award will be based on an evaluation of proposals against three factors.

The factors in order of importance are: technical (non-cost/price Factors 1 through 5), past performance (non-cost/price Factor 6 [performance confidence assessment]) and cost/price. Although technical factors are of paramount consideration in the award of the contract, past performance [performance confidence assessment] and cost/price are also important to the overall contract award decision. All evaluation factors other than cost/price, when combined are significantly more important than cost/price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

[Page 107 of RFP, Reference Amendment 2 Questions and Answers attachment, question 25]

ATTACHMENT 2 – STATEMENT OF WORK:

Section 1.6 Reports and Deliverables

As of the effective date of this RFP Amendment, the Research Plan deliverable contained in the deliverables table is hereby amended to read:

Research plan Section 3.1 For each new project, a work plan shall be submitted to the COR for approval.

Draft work plans shall be due within 2 weeks of receipt of a research outline from the COR and final work plans shall be due within 2 weeks of receipt of comments from the COR.

COR

[Page 4 of ATTACHMENT 2 Statement of Work, Reference Amendment 2 Questions and Answers attachment, question 28]

Section 4 Government Furnished Property and Services

The following clarifying language is hereby added to RFP ATTACHMENT 2, STATEMENT OF WORK, Section 4, “Government Furnished Property and Services” (pages 19-20):

Government-Issued PIV cards:

For those contractor (and subcontractor) staff identified by the NIEHS Information System Security Officer (ISSO) as needing an NIH-issued PIV card to conduct work under this contract, contractor staff must travel to one of the authorized NIH PIV Card Issuance Facilities at their own expense to obtain their NIH-issued PIV card (and as needed for any maintenance issues including, but not limited to, lost PIV cards or card deactivations). The Government will not reimburse travel costs related to PIV card activation/maintenance and pick up. Locations are limited to those indicated in the provided link below:

https://ors.od.nih.gov/ser/dpsac/contact/Pages/other-DPSAC-locations.aspx

Currently, the only authorized NIH PIV Card Issuance Facilities are in the following locations: Research Triangle Park/Durham, NC; Bethesda, MD; Rockville, MD; Frederick, MD; Baltimore, MD; Hamilton, MT and Phoenix, AZ.

Offerors should NOT include travel costs related to NIH Badge/PIV Card issuance and maintenance in their proposal budget as these costs will not be reimbursed by the Government.

Section 4.4 Equipment

As of the effective date of this RFP Amendment, Statement of Work Section 4.4 Equipment, second paragraph is hereby amended to read as follows:

If required to perform activities under the Contract, the Government will provide a secure laptop computer in order for the Contractor to have access to the VPN in use at NIEHS, given the proper security clearances are processed for the Contractor staff using the equipment. Contractor staff who are granted access to the NIEHS VPN will be required to comply with all NIH training requirements for the maintenance of these accounts.

ATTACHMENT 7 – CORPORATE EXPERIENCE PROJECT DATA FORM

A Microsoft Word version of this attachment is being provided as a separate attachment as requested [Reference Amendment 2 Questions and Answers attachment, question 5]

ATTACHMENT 11 – BUSINESS PROPOSAL TEMPLATE

Due to spreadsheet formula inconsistencies and mistakes discovered in the SUMMARY, EXECUTIVE SUMMARY and TOTAL ESTIMATE tabs, a revised [corrected] ATTACHMENT 11 Business Proposal Template is being provided as part of this RFP Amendment 2. Please utilize “ATTACHMENT 11 Revised…” in preparing and submitting your budget proposal. (Documents previously submitted to the NIH eCPS system will be https://ors.od.nih.gov/ser/dpsac/contact/Pages/other-DPSAC-locations.aspx automatically overwritten if submitting a revised proposal document any time prior to the closing date/time indicated -

- there is no need to withdraw previously submitted documents).

[Reference Amendment 2 Questions and Answers attachment, question 43]

QUESTIONS AND ANSWERS ATTACHMENT (17 pages) IS ATTACHED TO THIS RFP AMENDMENT 2

Amendment 2 ATTACHMENT – RFP Questions and Answers

RFP 75N9602500004

“Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences”

RFP Questions and Answers

General:

1. Given the recent award of the contract Station Support Services for the NIH Office of Research Innovation, Validation, and Application (NIH-OD-DPCPSI-2025-1) – which is of very similar size and scope to this procurement – would the Government please clarify anticipated collaboration and/or areas of alignment between the two contracts?

ANSWER: The current R&D solicitation is to support research conducted at NIEHS on toxicological evaluation using alternative approaches as stated in SOW Section 1. This requirement is completely distinct from the Station Support Services requirement referenced in the question. NIH will ensure appropriate collaboration, coordination and alignment among its research programs

2. Is the proposal required to be 508 compliant?

ANSWER: Yes. HHSAR 352.239-73, Electronic Information and Technology Accessibility Notice is hereby added to the RFP as Section L.1. General [Instructions], paragraph o. This solicitation provision, in part, states “…any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508.”

3. PI and PM are from Prime [contractor]…Is it feasible to have a co-PI from a subcontractor group?

ANSWER: A Co-PI from a subcontractor group is not acceptable. However, the prime contractor may propose critical professional personnel from the subcontractor group to be included in the research plan depending on the nature of study.

RFP Section F – DELIVERIES OR PERFORMANCE:

4. RFP page 15, Article F.3. Level of Effort, paragraph a. -- Please confirm that subcontractor labor hours are not excluded from the level of effort table to be proposed.

http://www.hhs.gov/web/508

ANSWER: The RFP erroneously states “These labor hours exclude subcontractor labor hours”.

RFP Article F.3. Level Of Effort, paragraph a. is hereby amended to read “These labor hours include subcontractor labor hours”.

RFP Section J – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

5. Please provide a Word version of Attachment 7.

ANSWER: A Word version of Attachment 7, “Experience Form”, is provided with this RFP Amendment 2.

6. Please provide the NIH Technical Proposal Cost Summary attachment referenced in Section L.3.1.B., page 75 of RFP).

ANSWER: A Technical Proposal Cost Summary attachment is added via this RFP Amendment 2 as ATTACHMENT 17. Please complete and provide as part of your Technical Proposal (does not contain pricing data related to individual salary information, indirect cost rates or amounts, fee amounts and total costs).

Please note this is separate from the Budget Proposal Template (ATTACHMENT 11). Please see a later section contained in this list of questions and answers for questions regarding RFP Attachment 11, Budget Proposal Template.

A Technical Proposal Cost Summary (newly added Attachment 17) should be submitted as part of the Technical Proposal. This should also be completed for each proposed subcontract, as applicable.

Separately, the Budget Proposal Template (ATTACHMENT 11) needs to be completed and submitted.

RFP Section L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

7. RFP pages 70-71, Article L.1.d. Level of Effort tables – Do the level of effort estimates provided represent the minimum required effort, or may offerors propose alternate LOE structures if they can demonstrate equivalent technical coverage?

RELATED QUESTION: What is the current number of contractor resources provided by the incumbent supporting all of the task areas?

ANSWER: The Level of Effort estimates provided in the RFP are based both on previously incurred effort under the prior recently completed contract and anticipated future needs moving forward under the pending future contract (to be awarded under this RFP). Given that exact requirements cannot be determined in advance, the contract type will be cost reimbursement, term, level-of-effort. In actual performance of the contract requirements, actual needs may change over time involving re-allocation of the overall annual awarded hours and budgeted amounts among the projects (and numbers of projects) described in the Research Outlines.

As such, the cost assumptions provided in the RFP are intended to provide sufficient cumulative resources to meet changing needs over time across all Research Outlines/Capability Areas with the realization that changes may be made among the Capability Areas withing the overall annual awarded budgets as needed.

Given the uncertainties regarding actual needs among the various Capability Areas, though the effort estimates in the RFP are not prescriptive, the Government would consider significant variances in proposed overall hours from the effort estimates provided in the RFP to represent a potential risk of a cost overrun without additional justification provided by the offeror in the technical and cost proposals.

All cost proposals will be evaluated on the basis of cost realism analysis for the anticipated cost plus fixed fee type contract. Therefore, if an offeror is proposing notably less overall effort than the effort estimates provided in the RFP an offeror must demonstrate in their proposal that all anticipated work can indeed be performed with less overall effort in accordance with their unique technical approach. This is to ensure a fair evaluation of cost proposals (and to not give any competitive advantage to unrealistic “low ball” offers as this will be a cost reimbursement-type contract whereby the Government assumes the risk of a cost overrun).

Please note that in accordance with RFP Section M, EVALUATION FACTORS FOR AWARD, “all technical factors and the performance confidence assessment (past performance) rating, when combined are significantly more important than cost [in selection of contract awardee]”.

8. RFP pages 75-76, Article L.3. Submitting Your Proposal – Will the Government allow subcontractors to submit portions of their business or cost proposal (e.g. proprietary rate information) directly to the Government in a sealed package, separate from the prime contractor’s submission? How should their files be named and submitted?

ANSWER: It is generally expected that any proposed subcontractors submit a complete cost proposal in the same format as the offeror’s cost proposal [ATTACHMENT 11 – Business Proposal Template] to the prime offeror for inclusion with the prime offeror’s Business Proposal (see RFP page 93, item 1.9.f. under Factor 2, Program and Project Management and Coordination).

If, in particular instances, a proposed subcontractor insists that some specific cost information cannot be shared with the prime offeror, that particular proposed subcontractor may contact the Contracting Officer directly (jason.williams2@nih.gov) to request a secure mailto:jason.williams2@nih.gov e-mail that can be used to submit the full subcontract proposal budget details directly to the Government. All information must be received on or before the due date/time for proposals in response to the RFP.

Total subcontract costs must be submitted to the prime offeror for inclusion in the prime offeror’s Business Proposal budget/Business Proposal Template ATTACHMENT 11. (Also see answer provided to question 42 below).

To mitigate confusion and provide standardization on how to include subcontractor costs in ATTACHMENT 11 – Business Proposal Template, the template has been revised to include a “Subcontract” costs line in each of the Research Outline Tabs, the Website Maintenance Tab and Training Tab (as Line 12, below the “Other Direct Costs” line). Additionally, offerors will be requested to include subcontracted hours in the SUMMARY Tab, fields C3:C13.

Additionally, in order for the Government to evaluate the prime offeror’s understanding of the project in terms of overall labor and resources needed/proposed, any major subcontractor [in terms of labor hours] should also complete the Technical Proposal Cost Summary (Section J, Attachment 7 of the RFP) for inclusion with the prime offeror’s Technical Proposal. This does not include individual salary info, indirect costs, fee, etc., only assigned roles and associated hours and cumulative subcontractor direct costs – see page 74 of the RFP for full details). The Government is primarily interested in the assigned roles/hours for labor to assess overall labor mix and “coverage”.

This Technical Proposal Cost Summary can be accessed via the below link:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

Please note that, should the prime offeror be awarded the contract, any subcontractor will be submitting invoices and any necessary supporting price information directly to the prime contractor. NIH does not accept subcontract invoices directly as there is no privity of contract between NIH and subcontractors.

9. RFP page 75, Article L.3.I.B. Submitting Your Proposal – Proposal Submission, Creating and

Naming Files – The RFP states “The technical proposal must include direct cost information, such as labor-hours and categories and applicable rates, materials, subcontractors, travel etc.., and associated costs so that the offeror’s understanding of the project may be evaluated (See Section J, Attachment entitled TECHNICAL PROPOSAL COST SUMMARY). Please provide the Technical Proposal Cost Summary attachment.

ANSWER: The Technical Proposal Cost Summary attachment is added to the RFP as ATTACHMENT 17 via this Amendment 2 to the RFP. (Also see similar Question/Answer number 5, above).

10. RFP page 76, Article L.3.II. Formatting and Page Limitations – RFP Section L.3 (Proposals Submission Requirements) specifies formatting for proposal submissions. Can the Government confirm whether font size 10 may be used in tables, figures, and graphics, provided the text remains legible, while maintaining the required minimum font size for narrative text?

ANSWER: A 12-point font is required for all narrative text; however, minimal use a 10-point font may be utilized for tables, figures and graphics ONLY for purposes of formatting and as needed to prevent or minimize page “run-offs” for tables/figures/graphics. Again, all narrative text is to be 12-point font.

11. RFP page 76, Article L.3.II Formatting and Page Limitations – Would the Government permit offerors to include an Acronym List that would not count toward the page limits for the Technical and Business Proposals?

ANSWER: Yes, an acronym list can be excluded from the page limits for the Technical and Business Proposals.

12. RFP page 77, Article L.4.A1.e. Proposal Submittal Instructions, Business Proposal, Mandatory

Criteria, Conformance to Section 508 Standards, Voluntary Product Accessibility Template (VPAT) -- Does the VPAT go in the business proposal (page 77) or in the Technical Proposal (page 108)?

ANSWER: Please provide the VPAT with the Business Proposal. (It can admittedly be a bit confusing in these lengthy RFP documents, but on a macro level the language in Section L [Proposal Instructions] provides instructions on how to prepare/submit your proposal in order for it to be evaluated favorably and in alignment with the proposal evaluation scheme described in Section M [Evaluation Factors for Award], inclusive of the page 108 language concerning evaluation of Conformance to Section 508 Standards).

13. RFP page 82, Article L.4.A1.n., Business Proposal Instructions, NIH Form 2706 Financial

Report of Individual Project/Contract – The Business Proposal Instructions ask for the submission of Attachments 15 and 16. The attachments seem to be for invoicing after contract award. Please clarify.

ANSWER: Attachments 15 (NIH Form 2706) and 16 (NIH RC-1) are indeed intended as informational attachments only. As such, the Business Proposal Instruction item n. is removed In its entirety via this RFP Amendment 2. There is no need for offerors to complete/submit these two informational attachments (Section J, Attachments 15 and 16) with their proposals.

14. RFP page 84, Article L.4.A.2. Cost Factor, second paragraph above Table 1 – Can the Principal

Investigator be included in the “Admin RO” tab [Attachment 11, Budget Template], in addition to the PM?

ANSWER: Yes.

15. RFP page 87, Article L.4.A.2. Table II: Assumptions for Meeting Support – Could the

Government explain what is meant by Specific Scientific Meetings? How do these differ from workshops/symposiums/webinars/seminars, and expert group meetings?

ANSWER: Specific Scientific Meetings refer to broader Scientific meetings with a specific investigator or investigating team regarding a specific item, area of scientific inquiry, or public health need. Those are different from workshops or expert group meetings. Workshops are interactive sessions to have collaborative discussion on certain technical questions/topics with various presentations while expert group meetings involve larger groups of experts from various fields to address complex issues.

16. RFP page 92, Article L.4.B.2.(2).(i). – Factor 2 -- Program and Project Management and Coordination – The RFP calls for the offeror’s “draft Information Technology Security Plan” to be included in Factor 5. Additionally, the Evaluation Criteria for Factor 5 indicates that the “adequacy of the proposed IT Security Plan” will be evaluated with this Factor [Factor 5].

However, the “Solicitation Submittal Requirements” for Factor 2 also reference an Information Technology Security Plan as an appendix to Factor 2. Would the Government please confirm that the Offeror’s IT Security Plan should be featured as an appendix to Factor 5 only, and not in Factor 2?

ANSWER: It is confirmed that the offeror’s draft Information Technology Security Plan should be featured as an appendix to Factor 5 only. The reference to the Information Technology Security Plan at the end of paragraph (2)(i) on RFP page 92 is hereby deleted via this RFP Amendment 2.

17. RFP pages 93-94, Article L.4.B.2.(2)(i) – Factor 2 – Program and Project Management and Coordination -- On page 93, the RFP requests a 2-page description for each Key Personnel to be included in the proposal body. On page 94, 2.4 [For PI provide…] and 2.5 [For PM provide…] call for additional detail for the PI and PM respectively. Would the Government please confirm that the descriptions required in 2.4 and 2.5 should be presented separately from the content provided in 2.1 and that this content does not count toward the 2-page limit per personnel set forth in 2.1 [Provide a description for each personnel]?

ANSWER: Sections 2.4 and 2.5 are what is expected, at the minimum, to be included in the 2-page description. Section 2.1 is intended as general formatting information and is not intended to mean a stand-alone section/document.

18. RFP pages 93, 96, Article L.4, Technical Proposal Factor 2 – Program and Project Management (page 93) and Factor 4 – Personnel (page 96) – Should offerors include descriptions of the PI and PM in the Factor 4 response as well as Factor 2 under section 4.1.2 – Description of Critical Personnel?

ANSWER: Descriptions of PI and PM are under section 2 while section 4.1 should include other professional personnel.

19. RFP page 94, Article L.4.B.2(3)(i) – Technical Proposal Factor 3 – Technical Approach and Sample Research Outlines – The RFP states “The response to Research Outline 7 should not include detail but focus on the thought process in developing a research program to meet the described objectives”. Please provide additional clarity on “the thought process in developing a research plan”.

ANSWER: Research Outline 7 is to support the conduct of a Workshop. The Government is expecting the offeror to provide information on how/what would be processed before, during and after a Workshop regarding the milestone and staffing plan proposed in the research plan.

20. RFP page 96, Article L.4.B.2(4)(i) – Technical Proposal Factor 4 – Personnel item 1.3 Biographical sketches – For ease of reference, would the Government permit offerors to include all Biographical Sketches within a single Appendix? If not, please clarify where the Biographical Sketches for Key Personnel should be included. Both Factor 2 and Factor 4 refer to Biographical Sketches for Key Personnel.

ANSWER: Factor 2 shall include biographical sketches for PI and PM while Factor 4 shall include biographical sketches for professional and technical personnel.

21. RFP pages 93 (Article L.4.B.2, paragraph 2.2), 94 (Article L.4.B.2, paragraph 3.2) and 96 (Article L.4.B.2, paragraph 1.3) – Biographical Sketch template – The Biographical Sketch template included as Attachment 8 to RFP uses a form that was approved through 9/30/2024. On the NIH website, a version of the biosketch template that is approved through 1/31/2026 and has slightly different information fields and headings is provided at

Biosketch (Non-Fellowship): Biographical Sketch Format Page | Grants & Funding. Can the Government clarify whether we are allowed to use the version of the biosketch template that is available on the NIH website?

ANSWER: Yes, the updated version is acceptable.

22. RFP pages 97-98, Article L.4.B.2(5).(i) paragraph 2 Information Technology Security Plan requirements – What is the FIPS 199 security categorization level for this system?

ANSWER: See ATTACHMENT 2, Statement of Work, pages 28-29 (SOW appendix A)

23. RFP pages 97-98, Article L.4.B.2(5).(i) paragraph 2 Information Technology Security Plan requirements – Will the contractor be expected to participate in a Security Assessment and https://grants.nih.gov/grants-process/write-application/forms-directory/non-fellowship-biographical-sketch-format

Authorization (SA&A effort)? If so, what is the expected level of involvement from the contractor. Are there any ongoing SA&A activities that should be included in the proposed budget?

ANSWER: It is not anticipated that the contractor will participate in any Security Assessment and Authorization (SA&A effort). The Government will provide the contractor access to NIH electronic resources as described in Statement of Work Section 4. 1..

24. RFP page 97-98, Article L.4.B.2(5).(i) paragraph 2 Information Technology Security Plan requirements – Will the contractor be required to submit a Privacy Impact Assessment ?

ANSWER: See ATTACHMENT 2, Statement of Work, page 29 (SOW appendix A)

Section M – Evaluation Factors for Award

25. RFP page 107, Article M.1. Basis for Award, Item 5 – COMMENT/SUGGESTION To promote competition, foster a level playing field, and increase the potential for innovative solutions, the Government would benefit from revising M.1.5. to make all six factors of equal importance (rather than the performance confidence assessment being most important), and when combined to be significantly more important than price. This would provide the Government with more latitude to award a contract to an offeror whose integrated solution across all factors presents the best value to the Government.

ANSWER: The Government has considered this suggestion and Section M.1.5. is hereby revised to read as follows:

Selection of an offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: technical (non-cost/price Factors 1 through 5), past performance (non-cost/price Factor 6 [performance confidence assessment]) and cost/price. Although technical factors are of paramount consideration in the award of the contract, past performance [performance confidence assessment] and cost/price are also important to the overall contract award decision. All evaluation factors other than cost/price, when combined are significantly more important than cost/price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

26. RFP page 108, Section M Evaluation Factors for Award, Article M.2. Mandatory Qualification Criteria – The RFP states that the offeror “shall provide an index within its proposal as stated below which directs the reviewer(s) to the specific area(s) of the proposal that address a particular mandatory qualification (as listed in Section L).” Since the mandatory criteria will be addressed in both the technical and business volumes, could the Government please confirm that the index should appear in both volumes?

ANSWER: Yes, confirmed. The Section 508/VPAT shall be included in the Business Proposal. The Data Management and Sharing Plan and the Plan for Sharing Model Organisms for Biomedical Research shall be included in the Technical Proposal.

27. RFP page 111, Section M Evaluation Factors for Award, Factor 2 Program and Project Management and Coordination, item i.2. Principal Investigator and Program Manager, last sentence – The evaluation criteria for the PM state: “Appropriateness of the education, training, experience, scientific expertise, competency, and accomplishments of the proposed Program Manager (as demonstrated in the biographical sketch) familiar with the organization, management and coordination of scientific review and evaluation activities…”. By scientific review and evaluation, do you mean NAMs activities?

ANSWER: Scientific review and evaluation activities for Program Manager are not solely for research activities (e.g., NAMs), but rather including broader activities related to science, performance, planning, etc.

ATTACHMENT 2 – STATEMENT OF WORK

28. Page 4 ATTACHMENT 2 Statement of Work (Section 1.6 Reports and Deliverables) – Table row for “Research Plan” – The table shows that the Research Plan is due 2 days after receipt of research outline, and final work plans are due 2 days after receipt of comments from the COR.

But the SROs (for example, see page 2 of Attachment 6) says that the Research Plan is due 2 weeks after request. Should it be 2 days or 2 weeks after receiving the request, and then 2 days or 2 weeks to respond to comments?

ANSWER: Attachment 2, Statement of Work page 4, Section 1.6 Reports and Deliverables), Table row for Research Plan is hereby revised to read “2 weeks after receipt of the research outline, and final work plans are due 2 weeks after receipt of comments from the COR.”

29. Page 12 ATTACHMENT 2 Statement of Work (Section 2.2 Research, Development and

Validation of Computational Toxicological Approaches), third paragraph – The SOW states “The Contractor shall utilize information from diverse data streams and multiple databases (e.g., ICE, ToxRefDB, ToxCast, ExpoCast, DSSTox [….]) to assist the Government in developing, evaluating, and/or comparing the approaches listed above”. Do we only have to only use existing data or new (in vitro) data can also be generated to support the modeling?

ANSWER: Depending on research needs and the nature of the study design, the contractor may use existing data or generate new data to support the modeling.

30. Page 12 ATTACHMENT 2 Statement of Work (Section 2.2 Research, Development and Validation of Computational Toxicological Approaches) – This section describes contractor support for toxicogenomics, high-throughput screening, PBPK, QSAR, AI/ML, and other computational method. Can the Government clarify whether the contractor is expected to generate new data in these areas, or focus solely on the analysis and interpretation of existing Government- or externally generated data?

ANSWER: Depending on research needs and the nature of the study, the contractor may analyze new data generated by this contract or existing data which are publicly available.

31. Pages 12-13 ATTACHMENT 2 Statement of Work (Section 2.2 Research, Development and Validation of Computational Toxicological Approaches) – This section regarding Data Management references management and maintenance of data resources in support of alternative toxicological methods. Can the Government clarify its expectations for data storage and hosting, specifically whether data must reside on Government-furnished infrastructure (e.g. NIH Cloud One STRIDES, or equivalent) or whether contractor-managed servers will be required?

ANSWER: The final data and other deliverables must be stored on NIEHS servers. Interim data can be temporarily stored on contractor-managed servers. Please refer to Attachment 2 Statement of Work, Section 3 “Operating Procedure”.

32. Pages 14 and 26 ATTACHMENT 2 Statement of Work (Section 2.4 and Section 8.2.4) – What is the current NIH-approved web-based platform(s) for hosting webinars and virtual events? Will the platform(s) be provided to the contractor or will they need to be procured?

ANSWER: The current NIH-approved web-based platform for hosting webinars and virtual events is Microsoft Teams. This platform will be provided by NIEHS to the contractor (and will not need to be procured by the contractor). The contractor will be provided instructions on how to access the NIEHS-provided platform for virtual event support.

33. Pages 14-15 ATTACHMENT 2 Statement of Work (Section 2.4 Meeting Support and Event

Hosting) – This section references support for meetings, workshops, and transcription. Can the Government clarify whether these meetings are expected to be primarily in-person at NIEHS, hybrid, or virtual? Can the Government also clarify how many meeting are expected to be supported?

ANSWER: Please reference Section L.4.A.2. beginning on page 83 of the RFP for cost assumptions to assist in preparing your cost proposal. Meeting and travel cost information if provided on pages 86-88.

34. Pages 16-17 ATTACHMENT 2 Statement of Work (Section 3.1 Operating Procedures/Project Management) – The SOW states “The contractor shall maintain records on all activities of DTT/NIEHS.” If this included non-contract activities, how will we access this information?

ANSWER: The Government will identify and provide instructions for any necessary contractor access to such information, as needed, in the course of contract performance.

35. Page 19 ATTACHMENT 2 Statement of Work (Section 4.1 Government-Furnished Property and

Services – Supplies and Services) – This section describes materials and electronic resources (e.g.

test agents, NIEHS/NIH VPN access, library resources, content management software, and web-based tools) to be provided by the Government. Can the Government clarify whether contractor access will also include prior contract deliverables and models, and confirm the format and timeline by which Government-furnished databases and resources will be made available at the start of performance?

ANSWER: Depending on the research needs, the government may provide prior contract deliverables and instructions at an appropriate time (e.g., upon the research outline assigned).

36. ATTACHMENT 2 Statement of Work Information Technology Application Design, Development, or Support [question references “Section D”] – Can the Government confirm if they will provide licenses for the software needed to conduct analyses?

ANSWER: Generally speaking, there are three types of licenses -- 1) Government will provide licenses of certain software required and developed by NIEHS for specific study; 2) Contractor will provide basic, essential software (e.g., Microsoft Office, Adobe Acrobat Pro, EndNote); 3) for some projects, the Government will reimburse the contractor to purchase software which can benefit the project progression upon approval (none identified by the Government at this time).

Also, depending on the needs and requirements, the Government may provide GFE-laptops which will be equipped with software needed.

To provide some additional clarification, Statement of Work Section 4.4. Equipment (page 20), second paragraph is hereby revised to read as follows:

“If required to perform activities under the Contract, the Government will provide a secure laptop computer in order for the Contractor to have access to the VPN in use at NIEHS, given the proper security clearances are processed for the Contractor staff using the equipment. Contractor staff who are granted access to the NIEHS VPN will be required to comply with all NIH training requirements for the maintenance of these accounts.”

ADDITIONAL LANGUAGE ADDED TO RFP ATTACHMENT 2 – STATEMENT OF WORK VIA

THIS RFP AMENDMENT 2:

The following clarifying language is hereby added to RFP ATTACHMENT 2, STATEMENT OF WORK, Section 4, “Government Furnished Property and Services” (pages 19-20):

Government-Issued PIV cards:

For those contractor (and subcontractor) staff identified by the NIEHS Information System Security Officer (ISSO) as needing an NIH-issued PIV card to conduct work under this contract, contractor staff must travel to one of the authorized NIH PIV Card Issuance Facilities at their own expense to obtain their NIH-issued PIV card (and as needed for any maintenance issues including, but not limited to, lost PIV cards or card deactivations). The Government will not reimburse travel costs related to PIV card activation/maintenance and pick up. Locations are limited to those indicated in the provided link below:

https://ors.od.nih.gov/ser/dpsac/contact/Pages/other-DPSAC-locations.aspx

Currently, the only authorized NIH PIV Card Issuance Facilities are in the following locations: Research Triangle Park/Durham, NC; Bethesda, MD; Rockville, MD; Frederick, MD; Baltimore, MD; Hamilton, MT and Phoenix, AZ.

Offerors should NOT include travel costs related to NIH Badge/PIV Card issuance and maintenance in their proposal budget as these costs will not be reimbursed by the Government.

ATTACHMENT 6 – SAMPLE RESEARCH OUTLINES

37. ATTACHMENT 6 Sample Research Outlines [general] – Seven sample research outlines are described in Attachment 6 as example research activities under this contract. Will each research project last 12 months? In other words, will there be 7 research projects each year? Or are there projects that will be estimated to take more than one year to complete, meaning that there could be more than 7 or less than 7 projects per year?

ANSWER: Please reference cost assumptions contained in Section L beginning on page 83. In general, offerors are to assume that the sample Research Outlines ( except for RO III, which has been divided into Phases I and II such that the assigned work can be conducted within a period of performance of one year or less) contained in Table 1 on pages 84-85 will be conducted (in full) in the contract year listed in the table. The number of projects per year are estimates only and may, in practice, vary from year to year based upon evolving and changing needs. The cost reimbursement, term, level of effort contract type will allow for re-allocation of resources among the various Research Outlines/performance areas within the overall awarded hours/budget for each annual funding period.

ATTACHMENT 11 – Business Proposal Template https://ors.od.nih.gov/ser/dpsac/contact/Pages/other-DPSAC-locations.aspx

NOTE: Due to spreadsheet formula inconsistencies and mistakes discovered in the SUMMARY, EXECUTIVE SUMMARY and TOTAL ESTIMATE tabs, a revised [corrected] ATTACHMENT 11…