RFP 75N96025R00004.pdf

REQUEST FOR PROPOSALS (RFP) 75N96025R00004

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: 42 U.S.C. 285l

2. Request for Proposal (RFP) Number:

75N96025R00004

3. Issue Date:

September 17,

4. Set Aside: 100% Small Business Set Aside [ ] No [X] Yes See Part IV Section L

5. Title : Support for Evaluating and Conducting Computational and Alternative Toxicological Methods for the National Institute of Environmental Health Sciences

6. ISSUED BY:

Office of Acquisitions, ARB, Eunice Kennedy Shriver National Institute of Child Health and Human Development (on behalf of the National Institute of Environmental Health Sciences), NIAAA & NIEHS Team

6700B Rockledge Drive, MSC 6902 Bethesda, MD 20892-6902

7. SUBMIT OFFERS TO:

See Part IV, Section L.3

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received as specified in Part IV, Section L.3, "Packaging and Delivery of Proposals”, until 4:30 PM Eastern Standard Time on November 3, 2025. Offers will be valid for 300 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043”.

9. This solicitation requires delivery of proposals as stated in Part IV, Section L.3, "Packaging and Delivery of Proposals”. Proposal is to be delivered electronically via the NIH electronic Contract Proposal Submission (eCPS) website, https://www.ecps.nih.gov

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR

HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED IN SECTION L.3 OF THE

RFP, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE

WITH subparagraph (c)(3) of FAR Provision 52.215-1, Instructions to Offerors-- Competitive Acquisition,"/HHSAR Provision 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/ .

11. FOR INFORMATION CONTACT: Jason Williams, Contracting Officer e-MAIL: jason.williams2@nih.gov Phone: 301-443-3877

COLLECT CALLS WILL NOT BE ACCEPTED.

Questions must be submitted in writing via e-mail to jason.williams2@nih.gov and lisa.schaupp@nih.gov in accordance with Article L.2., by October 20, 2025.

Secondary Contact:

Lisa Schaupp, Section Chief, NICHD ARB, NIAAA and NIEHS Team, lisa.schaupp@nih.gov

Table of Contents

SECTION A - SOLICITATION/CONTRACT FORM

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. ESTIMATED COST PLUS FIXED FEE – OPTION

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

ARTICLE B.4. ADVANCE UNDERSTANDINGS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. DELIVERIES

ARTICLE F.3. LEVEL OF EFFORT

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

ARTICLE G.2. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND

CONTRACT FINANCIAL REPORT

ARTICLE G.3. CONTRACT FINANCIAL REPORT

ARTICLE G.4. INDIRECT COST RATES

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

ARTICLE G.6. GOVERNMENT PROPERTY

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR

AND TRANSPARENCY

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING

INFORMATION

ARTICLE H.6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.7. GUN CONTROL

ARTICLE H.8. OPTION PROVISION

ARTICLE H.9 OTHER IT PROCUREMENTS

ARTICLE H.10. COMMUNICATIONS MATERIALS AND SERVICES

ARTICLE H.11. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC

MAIL

ARTICLE H.12. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

ARTICLE H.13. CONFIDENTIALITY OF INFORMATION

ARTICLE H.14. RECORDS MANAGEMENT……….. 25

ARTICLE H.15. HHSAR 352.204-74 Supply Chain Risk Assessment (OCT 2024) (DEVIATION)

ARTICLE H.16. SUPPLY CHAIN RISK ASSESSMENT DURING CONTRACT

PERFORMANCE …….. 31

ARTICLE H.17. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR

FINANCIAL CONFLICTS OF INTEREST

ARTICLE H.18. PUBLICATION AND PUBLICITY

ARTICLE H.19. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.20. SHARING RESEARCH DATA

ARTICLE H.21. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.22. GOVERNMENT CONTROL OVER UNDELIVERED AND/OR

UNPUBLISHED RECORDS AND DATA

ARTICLE H.23. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

ARTICLE H.24. GUIDELINES FOR INCLUSION OF WOMEN, MINORITIES, AND

PERSONS WITH DISABILITIES IN NIH-SUPPORTED CONFERENCES

ARTICLE H.25. USE OF FUNDS FOR PROMOTIONAL ITEMS

ARTICLE H.26. INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE HHSAR 352.279-78 (DEVIATION)………. 44

ARTICLE H.27. INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY HHSAR 352.279-79 (DEVIATION)……….. 46

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES

ARTICLE I.2. ADDITIONAL CONTRACT CLAUSES INCLUDED IN FULL TEXT

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - List of Documents, Exhibits and Other Attachments

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

ARTICLE L.0. PROPOSAL INTENT

ARTICLE L.1. GENERAL

ARTICLE L.2. PRE-AWARD INQUIRIES/REQUEST FOR PROPOSALS (RFP)

INFORMATION/ CLARIFICATIONS/QUESTIONS

ARTICLE L.3 SUBMITTING YOUR PROPOSAL

ARTICLE L.4. PROPOSAL SUBMITTAL REQUIREMENTS

ARTICLE L.5. PROVISIONS AND CLAUSES

SECTION M - EVALUATION FACTORS FOR AWARD

ARTICLE M.1 BASIS FOR AWARD

ARTICLE M.2 MANDATORY QUALIFICATION CRITERIA

ARTICLE M.3 EVALUATION FACTORS CRITERIA

ARTICLE M.4 ADJECTIVAL RATINGS/DESCRIPTIONS

ARTICLE M.5 PROVISIONS AND CLAUSES

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT

FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR

INTERESTED IN RESPONDING TO THIS SOLICITATION. ANY CONTRACT

RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND

GENERAL INFORMATION APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN,

CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT

IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL

BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR

PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR

(i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE

INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT

SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY

INFORMATION TO UNDERSTAND THE TERMS AND CONDITIONS OF THE

RESULTANT CONTRACT.

NOTE: If any LINK in this solicitation is not clickable, manually copy and paste the URL into your web browser.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The acquisition will support and assist the National Institute of Environmental Health Sciences (NIEHS) by conducting and evaluating toxicological testing using computational and/or alternative approaches, also referred to New Approach Methodologies (NAMs). NAMs broadly refers to any technology, methodology, approach, and/or combination of the three that can provide information on chemical hazard and risk assessment without the use of animals, such as in silico, in chemico, in vitro, and ex vivo approaches. The areas of focus for the research include but are not limited to population variability, susceptibility, developmental neurotoxicity, carcinogenicity, ecotoxicity, acute toxicity, etc.

The outputs from this requirement will directly feed into the mission of the Department of Health & Human Services (HHS). This requirement would produce information to predict adverse human health effects from chemical exposures while also replacing, reducing, or refining the use of animals in toxicity testing. These services are necessary to support state of the art alternative toxicity testing at NIEHS. This acquisition is for continuing support services for alternative toxicological testing approaches that extend beyond the scope or capability of in-house staff.

ARTICLE B.2. ESTIMATED COST PLUS FIXED FEE – OPTION

Note: To be completed upon award. See Section L, Proposal Instructions, for further information on estimating hours. Article L.1.d. provides the Government’s estimated effort; Article l.4.A.2. and ATTACHMENT 6 – Sample Research Outlines provide further detailed information as to anticipated types/quantities of work.

a. The estimated cost of the Base Period of this contract is $ TBD .

b. The fixed fee for the Base Period of this contract is $ TBD . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ TBD .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Period Period of Performance Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Level of Effort

(LOE)

Hours

Base Period 6/1/2026 – 5/31/2027

Option Period 1 6/1/2027 – 5/31/2028

Option Period 2 6/1/2028 – 5/31/2029

Option Period 3 6/1/2029 – 5/31/2030

Option Period 4 6/1/2030 – 5/31/2031

Option Period 5 6/1/2031 – 5/31/2032

Option Period 6 6/1/2032 – 5/31/2033

Option Period 7 6/1/2033 – 5/31/2034

Option Period 8 6/1/2034 – 5/31/2035

Option Period 9 6/1/2035 – 5/31/2036

Option to Extend Services up to 6 months IAW

FAR 52.217-8

6/1/2036 – 11/30/2036

Additional Level of Effort (LOE) Options, by performance period

Period of Performance

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Level of Effort

(LOE)

Hours

ADDITIONAL

LOE OPTION --

Base Period

6/1/2026 – 5/31/2027

ADDITIONAL

LOE OPTION --

Option Period 1

6/1/2027 – 5/31/2028

ADDITIONAL

LOE OPTION --

Option Period 2

6/1/2028 – 5/31/2029

ADDITIONAL

LOE OPTION --

Option Period 3

6/1/2029 – 5/31/2030

ADDITIONAL

LOE OPTION --

Option Period 4

6/1/2030 – 5/31/2031

ADDITIONAL

LOE OPTION --

Option Period 5

6/1/2031 – 5/31/2032

ADDITIONAL

LOE OPTION --

Option Period 6

6/1/2032 – 5/31/2033

ADDITIONAL

LOE OPTION --

Option Period 7

6/1/2033 – 5/31/2034

ADDITIONL

LOE OPTION --

Option Period 8

6/1/2034 – 5/31/2035

ADDITIONAL

LOE OPTION --

Option Period 9

6/1/2035 – 5/31/2036

Total Base Period and All Possible Options

Note: The period of performance of an option for increased level of effort will not exceed the term of the period in which the option is exercised.

Each item listed above may be incrementally funded (see Incremental Funding clause in Section I in full text, HHSAR 352.232-70). If incremental funding is utilized for one or more of the above items, a separate line item for each incremental funding action will be created and this Article will be modified accordingly.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable.

1) Conferences & Meetings

2) Food for Meals, Light Refreshments & Beverages

3) Promotional Items

4) Acquisition, by purchase or lease, of any interest in real property

5) Special rearrangement or alteration of facilities

6) Purchase or lease of any item of general-purpose office furniture or office equipment regardless of dollar value.

7) Travel Costs including Foreign Travel

8) Consultant Costs

9) Subcontract Costs

10) Patient Care Costs

11) Accountable Government Property

12) Printing costs

13) Research Funding

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes, please see the Statement of Work (ATTACHMENT 2 to this RFP), Section 1.6 “Reports and Deliverables”.

Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

3. HHS Security And Privacy Language For Information And It Procurements

Reporting requirements for HHS Security and Privacy Language for Information and Information Technology Procurements are applicable to this solicitation. Please see the Statement of Work Appendix A “HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS” (ATTACHMENT 2 to this RFP) for a list of applicable deliverables reporting requirements.

4. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_repor t.doc.

5. Service Contract Annual Report

The Contractor shall submit an Annual Service Contract Report to https://www.SAM.gov on or before November 15 each year (covering a reporting period of the applicable recently completed Federal Government Fiscal Year, October 1 through September 30), in accordance with FAR 52.204-14, Service Contract Reporting Requirements. The full text of this FAR clause is contained in Section I. This report is separate from the Service Contract Act, which does not apply to this requirement. The intent of this high-level reporting is for the Federal Government to assess the balance of in-house versus contracted-out work.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting

Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before the 30th day after the end of the fiscal year.

Thereafter, reports shall be due on or before the working day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract.

All reports shall be sent to the following address:

Contracting Officer’s Representative (COR): ________________________ (to be completed upon award)

Contracting Officer (CO): _________________________ (to be completed upon award)

Contract Specialist (CS): _________________________ (to be completed upon award)

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the COR is the authorized representative of the Contracting

Officer.

c. Inspection and acceptance will be performed at:

National Institute of Health National Institute of Environmental Health Sciences 111 T.W. Alexander Drive Research Triangle Park, NC 27709

d. INSPECT BY RECEIVING REPORT: This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

CLAUSES INCORPORATED BY REFERENCE:

Database Number Title Date

FAR 52.246-5 Inspection of Services—Cost-Reimbursement APR 1984 FAR 52.246-9 Inspection of Research and Development (Short Form) APR 1984

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 6/1/2026 through 05/31/2027.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 6/1/2027 - 5/31/2028 Option Period 2 6/1/2028 - 5/31/2029 Option Period 3 6/1/2029 - 5/31/2030 Option Period 4 6/1/2030 - 5/31/2031 Option Period 5 6/1/2031 - 5/31/2032 Option Period 6 6/1/2032 - 5/31/2033 Option Period 7 6/1/2033 - 5/31/2034 Option Period 8 6/1/2034 - 5/31/2035 Option Period 9 6/1/2035 - 5/31/2036 Option to Extend Services up to 6 months IAW FAR 52.217-8 6/1/2036 - 11/30/2036

ARTICLE F.2. DELIVERIES

a. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the Services specified in the Delivery Schedule which are described in SECTION C of this contract.

b. Deliveries required by the Contractor shall be made F.o.b. destination as set forth in FAR Clause

52.247-35, F.o.b. Destination, Within consignees Premises (April 1984) to the address/addressee listed below:

Delivery Address

Contracting Officer’s Representative, NIH/NIEHS

NIEHS

Research Triangle Park, NC 27709

c. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

ARTICLE F.3. LEVEL OF EFFORT

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 exclude subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

b.

Period Period of Performance Level of Effort

(LOE)

Hours

Base Period 6/1/2026 – 5/31/2027

Option Period 1 6/1/2027 – 5/31/2028

Option Period 2 6/1/2028 – 5/31/2029

Option Period 3 6/1/2029 – 5/31/2030

Option Period 4 6/1/2030 – 5/31/2031

Option Period 5 6/1/2031 – 5/31/2032

Option Period 6 6/1/2032 – 5/31/2033

Option Period 7 6/1/2033 – 5/31/2034

Option Period 8 6/1/2034 – 5/31/2035

Option Period 9 6/1/2035 – 5/31/2036

Option to Extend Services up to 6-months IAW

FAR 52.217-8

6/1/2036 – 11/30/2036

ADDITIONAL

LEVEL OF

EFFORT (LOE)

OPTIONS, by

Period

Period of Performance Level of Effort

(LOE)

Hours

ADDITIONAL

LOE OPTION --

Base Period

6/1/2026 – 5/31/2027

ADDITIONAL

LOE OPTION --

Option Period 1

6/1/2027 – 5/31/2028

ADDITIONAL

LOE OPTION --

Option Period 2

6/1/2028 – 5/31/2029

ADDITIONAL

LOE OPTION --

Option Period 3

6/1/2029 – 5/31/2030

Period Period of Performance Level of Effort

(LOE)

Hours

ADDITIONAL

LOE OPTION --

Option Period 4

6/1/2030 – 5/31/2031

ADDITION LOE

OPTION --

Option Period 5

6/1/2031 – 5/31/2032

ADDITIONAL

LOE OPTION --

Option Period 6

6/1/2032 – 5/31/2033

ADDITIONAL

LOE OPTION --

Option Period 7

6/1/2033 – 5/31/2034

ADDITIONAL

LOE OPTION --

Option Period 8

6/1/2034 – 5/31/2035

ADDITIONAL

LOE OPTION --

Option Period 9

6/1/2035 – 5/31/2036

Total Base Period and All Possible Options

NOTE: To be completed upon award. See Section L, Proposal Instructions, for further information on estimating hours. Article L.1.d. provides the Government’s estimated effort;

Article l.4.A.2. and ATTACHMENT 6 – Sample Research Outlines provide further detailed information as to anticipated types/quantities of work.

b. The Contractor shall have satisfied the requirement herein if not less than 90 % nor more than 110 % of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of hours by which the number of direct labor hours furnished is less than the number of direct labor hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

CLAUSES INCORPORATED BY REFERENCE:

Database Number Title Date

FAR 52.242-15 Stop-Work Order--Alternate I APR 1984 FAR 52.247-35 F.o.b. Destination, within Consignee’s Premises APR 1984

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

To be specified at time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The following Alternate Contracting Officer Representative (ACOR) will represent the Government for the purpose of this contract:

To be specified at time of award.

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.

The Government may unilaterally change its COR and/or ACOR designation.

ARTICLE G.2. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND

CONTRACT FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type

Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

Additionally, the Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer - TBD Email Address____________ Contracting Officer Representative - TBD Email Address ____________

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx .

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

A. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is

__________________. (To be identified at time of award)

B. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

C. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

D. Invoice Matching Option. This contract requires a two-way match.

E. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

F. The Contract Title is:

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

G. Inquiries regarding payment of invoices shall be directed to the designated billing office,

(301) 496-6452.

H. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.3. CONTRACT FINANCIAL REPORT

a. Financial reports on the attached Form NIH 2706, Financial Report of Individual Project/Contract, shall be submitted by the Contractor in accordance with the Instructions for Completing Form NIH 2706, which accompany the form, in an original and two copies, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are listed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

b. Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled "

PREPARATION INSTRUCTIONS," all columns A through J, shall be completed for each report submitted.

c. The first financial report shall cover the period consisting of the first full Three Calendar Months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a Quarterly basis.

d. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

e. The following is a listing of expenditure categories to be reported:

Expenditure Category A Percentage of Effort/Hours

(1) Direct Labor

(a) Principal Investigator

(b) Co-Principal Investigator

(c) Key Personnel (i) (ii) (iii)

(2) Other Professional Personnel

(3) Personnel - Other

(4) Fringe Benefits

(5) Accountable Personal Property

Expenditure Category A Percentage of Effort/Hours

(6) Materials/Supplies

(7) Patient Care Costs

(8) Travel

(9) Consultant Costs

(10) Premium Pay

(11) Computer Costs

(12) Subcontract Costs

(13) Other Direct Costs

(14) Indirect Costs

(15) G&A Expense

(16) Total Cost

(17) Fee

(18) Total Cost Plus Fixed Fee

f. The Government may unilaterally revise the NIH 2706 to reflect the allotment of additional funds.

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on DATES TBD.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted sixty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov .

ARTICLE G.6. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be found at:

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Gov ernment%20Property-Appendix%20Q.pdf

ARTICLE G.7. HHSAR 352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 calendar days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty calendar days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

The following individuals are considered to be essential to the work being performed hereunder:

Name Title To Be Named at Award PRINCIPAL INVESTIGATOR To Be Named at Award PROGRAM MANAGER

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR

AND TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources.

This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at https://grants.nih.gov/policy/reproducibility/index.htm, including FAQs and a General Policy Overview.

ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from any NIH-funded or conducted research, supported in whole or in part with direct costs from NIH regardless of NIH funding mechanism. NIH defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications that result from the publishing and peer review process, and which should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the award/support period, whichever comes first. The PMC archive will permanently preserve and retain these manuscripts for use by the public, health care providers, educators, scientists, and NIH. NIH Policy directs electronic submissions to the NIH/NLM/PMC:

https://www.ncbi.nlm.nih.gov/pmc/.

Additional information is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21- 013.html and https://publicaccess.nih.gov/.

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING

INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.6. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE H.7. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE H.8. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend Services, Contract Clause 1, Option for Additional Level of Effort, and FAR Clause 52.217-8, Option to Extend Services set forth in SECTION I.

of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 15 calendar days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST PLUS FIXED FEE Article in SECTION B of this contract.

ARTICLE H.9 OTHER IT PROCUREMENTS

ARTICLE H.9.1.1. HARDWARE PROCUREMENTS

1. Card Readers- The Contractor (and/or any subcontractor) must include Federal Information

Processing Standard (FIPS) 201-compliant smart card readers (referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

2. Mobile Devices- The Contractor must follow NIST 800-124, Rev. 1, Guidelines for Managing the Security of Mobile Devices in the Enterprise and comply with Public Law 115-232 § 889, when purchasing mobile devices that process or store HHS data.

ARTICLE H.9.1.2. NON-COMMERCIAL AND OPEN SOURCE COMPUTER SOFTWARE

PROCUREMENTS

The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by the United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP) that will limit system software vulnerability exploits. The Contractor will be liable for malicious or defective code or failure to reduce risk.

ARTICLE H.9.1.3. INFORMATION TECHNOLOGY APPLICATION DESIGN,

DEVELOPMENT, OR SUPPORT

a. The Contractor (and/or any subcontractor) must ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

b. The Contractor (and/or any subcontractor) must follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

c. The Contractor (and/or any subcontractor) must ensure that computer software developed on behalf of HHS or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS environment. No sensitive data must be used during software testing.

d. The Contractor (and/or any subcontractor) must protect information that is deemed sensitive from unauthorized disclosure to persons, organizations or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

ARTICLE H.10. COMMUNICATIONS MATERIALS AND SERVICES

To build and maintain public trust; promote credibility and consistency; minimize consistency and frustration; and contribute to efforts aimed at leveraging reduced resources and eliminating waste in Government, the Contractor shall ensure that all materials generated and/or services provided under this contract, comply with all applicable NIH policy and procedures published by the NIH Office of Management Assessment in conjunction with the NIH Office of Communications and Public Liaison as set forth below.

This acquisition requires the Contractor to:

[X] Prepare, review, and/or distribute NIH Publications and Audiovisuals.

NIH Policy Manual Chapter 1184, " Preparation and Clearance of Scientific, Technical, and Public Information Presented by NIH Employees or Produced for Distribution by NIH ," is applicable to this contract. https://policymanual.nih.gov/1184

[X] Use the NIH name and logo.

NIH Policy Manual Chapter 1186, "Use of NIH Names and Logos," is applicable to this contract. https://policymanual.nih.gov/1186

[X] Create and/or Manage a Public Website which includes NIH hosted social media site(s), Web application(s) and mobile Web Site ( s ).

NIHPolicyManualChapter2804*, " Websites and Digital Services - Management Policy," is applicable to this contract. https://policymanual.nih.gov/2804

[ ] Create and/or Manage an NIH Website that maintains and disseminates personal information.

NIH Policy Manual Chapter 2805*, "NIH Web Privacy Policy," is applicable to this contract. https://policymanual.nih.gov/2805

[ ] Create and/or Manage an NIH hosted and/or funded social media site(s), Web application(s) and mobile Web site(s). "NIH Social Media Guidelines," is applicable to this contract.

https://employees.nih.gov/pages/social-media/

* NOTE: NIH Policy Manual Chapters found in the 2800 series are currently only available to NIH personnel. If unavailable, contact the Contracting Officer for a copy.

Additional Standards applicable to this contract are identified in the Statement of Work. If it is determined by the Government that products, services, and deliverables provided by the Contractor do not conform to standards described in these directives, remediation to an acceptable level of conformance shall be the responsibility of the Contractor at its own expense.

ARTICLE H.11. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH)

ELECTRONIC MAIL

All Contractor staff that have access to and use of NIH electronic mail (e-mail) must identify themselves as Contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the Contractor staff shall set up an e-mail signature ("AutoSignature") or an electronic business card ("V-card") on each Contractor employee's computer system and/or Personal Digital Assistant (PDA) that will automatically display "Contractor" in the signature area of all e-mails sent.

ARTICLE H.12. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

The Contractor is authorized to use library resources at NIH in the same manner as NIH staff. The Contractor's approved use of these resources is limited to performing the requirements of this contract. The Contractor shall not use library resources at NIH in a manner that exceeds the Fair Use limitations codified in 17 U.S.C. sec. 107 of the Copyright Act. Contractors shall not share access to library resources at NIH with, perform searches for, or provide results to, non-NIH users, i.e.

collaborators at other universities or research centers.

ARTICLE H.13. CONFIDENTIALITY OF INFORMATION

1. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

2. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential.