75N96025R00001 Immunotox RFP.pdf

4. TYPE OF SOLICITATION 3. SOLICITATION NUMBER

RATING 1. THIS CONTRACT IS A RATED

ORDER UNDER DPAS (15 CFR 700)

NIEHS-OA

5. DATE ISSUED

SOLICITATION, OFFER AND AWARD

2. CONTRACT NUMBER

PAGE OF PAGES

1 103

6. REQUISITION/PURCHASE NUMBER

7. ISSUED BY CODE

National Institutes of Health National Institute of Environmental Health Sciences Office of Acquisition 530 Davis Drive Durham, NC 27713

8. ADDRESS OFFER TO (If other than Item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in until 4:00 PM EST local time

_________________2/18/2025_______

_____________ (Hour) CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)

10. FOR

INFORMATION

CALL:

A. NAME

ADAM B MUHSIN

B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

adam.muhsin@nih.govAREA CODE

+19

NUMBER

842-8741

EXT.

11. TABLE OF CONTENTS

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 6 X I CONTRACT CLAUSES 35

X B SUPPLIES OR SERVICES AND PRICES/COSTS 7 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 10 X J LIST OF ATTACHMENTS 52

X D PACKAGING AND MARKING 14 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 15 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

X F DELIVERIES OR PERFORMANCE 16

X G CONTRACT ADMINISTRATION DATA 19 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 54

X H SPECIAL CONTRACT REQUIREMENTS 25 X M EVALUATION FACTORS FOR AWARD 89

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 300 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

AWARD (To be completed by government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304 (c) ( ) 41 U.S.C. 3304 (a) ( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

ERICA W. KITZMILLER

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232.8)

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

14. ACKNOWLEDGEMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

AMENDMENT NO. DATE AMENDMENT NO. DATE

15A. NAME

AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

15B. TELEPHONE NUMBER 15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AREA CODE NUMBER EXT.

1/14/2025

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2 ESTIMATED COST – OPTION

ARTICLE B.3 ESTIMATED COST PLUS FIXED FEE

ARTICLE B.4 PROVISIONS APPLICABLE TO DIRECT COSTS

ARTICLE B.5 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

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 DUAL USE RESEARCH OF CONCERN

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.6 LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED

SUBSTANCES

ARTICLE H.7 DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

ARTICLE H.8 ANIMAL WELFARE

ARTICLE H.9 INTRODUCTION OF RODENTS AND RODENT PRODUCTS - NIEHS

ARTICLE H.10 PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

ARTICLE H.11 RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS

ARTICLE H.12 OMB CLEARANCE

ARTICLE H.13 RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.14 GUN CONTROL

ARTICLE H.15 OPTION PROVISION

ARTICLE H.16 SUBCONTRACTING PROVISIONS

ARTICLE H.17 STORAGE FACILITY REQUIREMENTS AND CERTIFICATION

ARTICLE H.18 ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL

ARTICLE H.19 CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

ARTICLE H.20 CONFIDENTIALITY OF INFORMATION

ARTICLE H.21 PUBLICATION AND PUBLICITY

ARTICLE H.22 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.23 OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

ARTICLE H.24 SHARING RESEARCH DATA

ARTICLE H.25 GOVERNMENT CONTROL OVER UNDELIVERED AND/OR UNPUBLISHED RECORDS

AND DATA

ARTICLE H.26 USE OF FUNDS FOR PROMOTIONAL ITEMS

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 CLAUSES AND PROVISIONS

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

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 A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority:

2. Request for Proposal

(RFP) Number:

75N96025R00001

3. Issue Date: 4. Set Aside:

[ X ] No

[ ] Yes See Part IV Section L

1. Title : Assessment of Immunotoxicity – In Vitro and In Vivo Assessment of Immune Function for the

National Institute of Environmental Health Sciences

6. ISSUED BY:

Office of Acquisitions

National Institutes of Health

National Institute of Environmental Health Sciences

530 Davis Drive

Morrisville, NC 27560

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 4:00 PM EST local time on 2/18/2025. 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”. If proposals are required to be delivered to two different locations, the OFFICIAL POINT

OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF

ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE

AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, 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 CALL: Adam Muhsin e-MAIL: adam.muhsin@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

SUBMIT ALL QUESTIONS IN WRITING VIA EMAIL TO

adam.muhsin@nih.gov ALL QUESTIONS MUST BE SUBMITTED

AS INSTRUCTED IN SECTION L.2.

Erica Kitzmiller

Contracting Officer

Office of Acquisitions

National Institute of Environmental

Health Sciences

1/14/2025 https://www.sam.gov/SAM/ mailto:adam.muhsin@nih.gov

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 providing all services and supplies necessary to conduct research studies to evaluate the potential for test agents selected by the Division of Translational Toxicology (DTT) to modulate immune function using established in vitro and in vivo models.

With the increasing awareness of the need for translational toxicology and to reduce the use of animals, the use of in vitro methods to assess immune function will be the focus of DTT’s research efforts to assess altered immunity. The focus of this requirement will be to provide DTT with a mechanism to evaluate chemical induced immunotoxicity by determining:

1) whether chemical or therapeutic agents can modulate the immune response using a battery of in vitro tests to measure immune suppression or stimulation in response to relevant antigens; 2) whether chemical agents have the potential to induce allergic responses using in chemico and in vitro OECD guideline test methods for skin sensitization as part of an integrated panel of tests and; 3) evaluate the potential of a test agent to modulate the immune system using a comprehensive in vivo immune testing panel that evaluates the major components of the immune system in the developing rat and/or adult mice or rats. In addition, because immunology is a developing science, it is expected that new and improved methodology will be required to maintain "state of the art" evaluation. As an additional optional capability area, the Contractor shall identify research gaps and conduct methods development and validation to support the use of new approach methodologies.

ARTICLE B.2 ESTIMATED COST – OPTION

Note: This section will be filled in upon award.

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

b. The fixed fee for the Base Period of this contract is $____________. The fixed fee shall be paid in direct ratio to the level of 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 $_______________.

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)

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Option Period 5

Option Period 6

Option Period 7

Option Period 8

Option Period 9

Optional 6-month

Extension IAW

FAR 52.217-8

Period - Optional

LOE Increase

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

Cost Plus

Fixed Fee ($)

Level of

Effort (LOE)

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Option Period 5

Option Period 6

Option Period 7

Option Period 8

Option Period 9

Total Base Period and All 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.

ARTICLE B.3 ESTIMATED COST PLUS FIXED FEE

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $________*.

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN,

Task, Number, or

Description

Start Date of

Period or

Increment of

Performance

End Date of

Period or

Increment of

Performance

Estimated

Cost ($)

Fee ($) (as appropriate)

Estimated

Cost Plus Fee

($) (as appropriate)

Level of

Effort

(LOE)

[Total] [Total] [Total] [Total}

*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $_________.

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

f. Payment of fee 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.

ARTICLE B.4 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.5 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.

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.

https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents 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. 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 for a list of applicable deliverables reporting requirements.

3. Section 508 Compliance Clause for Non-ICT Solicitations with ICT Deliverables

Scope and Applicability:

This clause shall apply to all Information and Communication Technology (ICT) deliverables, including but not limited to electronic documents, presentations, web content, multimedia, and official agency communications, provided under contracts where the primary focus is not ICT.

Compliance Requirements:

The Contractor shall ensure all ICT deliverables conform to the Revised 508 Standards (36 CFR Part 1194) and the applicable Web Content Accessibility Guidelines (WCAG) 2.0 Levels A and AA.

Documentation and Validation:

a. The Contractor must ensure that competently trained and knowledgeable personnel test and validate all ICT deliverables for adherence to the Section 508 Standards and the applicable WCAG 2.0 Levels A and AA.

b. Upon the Government's request, the Contractor shall provide Accessibility Conformance Reports (ACRs) for ICT deliverables in the following format: Voluntary Product Accessibility Template (VPAT) 508 located at: VPAT - Information Technology Industry Council The ACR must clearly document each ICT deliverable's conformance to the applicable WCAG criteria.

Non-Compliance and Remedial Actions:

In case of non-compliance, the Contractor must rectify or replace such deliverables at no additional cost within 30 days.

Agency Rights and Contractor Cooperation:

The agency reserves the right to independently validate compliance, with full cooperation required from the

Contractor.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fict%2F%23E103.4&data=05%7C01%7Cdan.rich%40nih.gov%7C03d6204c82194ed2477308dbeb711035%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638362643056688825%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=47eOPVvMzQv91iZ9UiAqmSRfJB8HhSYzw3wp2KKLtiU%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.access-board.gov%2Fict%2F&data=05%7C01%7Cdan.rich%40nih.gov%7C03d6204c82194ed2477308dbeb711035%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638362643056688825%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=AK7Nzk6MivWd4v1q8Uur9AhfbjL7ieYl8Jr4M2K8gN8%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.w3.org%2FTR%2FWCAG20%2F&data=05%7C01%7Cdan.rich%40nih.gov%7C03d6204c82194ed2477308dbeb711035%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638362643056688825%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=b4aPTa%2BPZ88yE1zY7lePb7k7lIkt2gi6ipVjosKWRrQ%3D&reserved=0 https://www.itic.org/policy/accessibility/vpat

HHS Digital Accessibility Conformance Standards

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this solicitation that are ICT, or contain ICT, must conform to all HHS digital accessibility conformance standards identified in the HHS Digital Accessibility

Conformance Checklists. The standards include the Revised 508 Standards, which are located at 36 C.F.R. §

1194.1 & Apps. A, B, & C, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when

Chapters 4-6 do not address one or more functions of ICT.

The standards listed below apply to all functionality of the supplies, products, platforms, information, documentation, training, and services that are part of this contract.

• 508 Chapter 2:

• E205 Electronic Content

• E206 Hardware

• E207 Software

• E208 Support Documentation and Services

• 255 Chapter 2:

• C203 Electronic Content

• C204 Hardware

• C205 Software

• C206 Support Documentation and Services

• Chapter 3: Functional Performance Criteria

• Chapter 4: Hardware

• Chapter 5: Software

• Chapter 6: Support Services and Documentation Requirements

Offerors must explain how the development/creation efforts associated with the objectives will be measured to achieve HHS digital accessibility conformance standards and meet the legal framework of Section 508 standards. For each proposed supply, license, product, or platform, a fully completed Accessibility

Conformance Report (ACR) must be submitted. An ACR can be built from the Voluntary Product

Accessibility Template (VPAT) , applicable HHS conformance checklist(s), or other agency conformance assessment template.

Prior to acceptance of deliverables, the Offeror must demonstrate conformance to the HHS digital accessibility conformance standards. The government reserves the right to perform testing on required ICT items to validate the Offeror’s digital accessibility and Section 508 conformance claims. If the government determines that conformance does not meet the HHS digital accessibility conformance standards, the government shall, at its option, require the Offeror to remediate the item, at no additional cost to the government, to align with the HHS digital accessibility conformance standards prior to acceptance.

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.access-board.gov/ict/ https://www.itic.org/policy/accessibility/vpat https://www.itic.org/policy/accessibility/vpat https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

References:

• Section 508 Standards: https://www.access-board.gov/ict/

• HHS Policy on Section 508 Compliance and Digital Accessibility of Information and Communications

Technology (ICT): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html

• HHS Digital Accessibility Conformance Checklists: https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

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, National Institutes of Health (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 30th calendar 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 filled in upon award)

Contracting Officer (CO):___________ _________________(to be filled in upon award)

Contract Specialist (CS):______________ ________________(to be filled in 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.

https://www.access-board.gov/ict/ https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html http://www.iedison.gov/

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 Institutes of Health

National Institute of Environmental Health Sciences

111 T.W. Alexander Drive

Research Triangle Park, NC 27709

d. This contract incorporates the following provisions and clauses 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 estimated period of performance of this contract shall be from 02/12/2026 through 02/11/2027.

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 Year 1 02/12/2027 - 02/11/2028

Option Year 2 02/12/2028 - 02/11/2029

Option Year 3 02/12/2029 - 02/11/2030

Option Year 4 02/12/2030 - 02/11/2031

Option Year 5 02/12/2031 - 02/11/2032

Option Year 6 02/12/2032 - 02/11/2033

Option Year 7 02/12/2033 - 02/11/2034

Option Year 8 02/12/2034 - 02/11/2035

Option Year 9 02/12/2035 - 02/11/2036

Optional 6- month Extension 02/12/2036 – 08/11/2036

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

Period Period of

Performance

Level of

Effort (LOE)

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Option Period 5

Option Period 6

Option Period 7

Option Period 8

Option Period 9

Optional 6-month

Extension IAW FAR

52.217-8

Period - Optional

LOE Increase

Period of Performance Level of Effort

(LOE)

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Option Period 5

Option Period 6

Option Period 7

Option Period 8

Option Period 9

Total Base Period and All Options

*Exact amounts will be determined at award. See Section L for further instructions on estimating hours.

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:3

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

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 and Contract Financial Reporting, NIH(RC)-1 for NIH

Cost-Reimbursement Type Contracts will be 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 shall submit a copy of the electronic invoice to the following Approving

Official (Contracting Officer) and Contracting Officer Representative:

https://www.ipp.gov/

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:

“Assessment of Immunotoxicity – In Vitro and In Vivo Assessment of Immune Function for the

National Institute of Environmental Health Sciences” mailto:ofm_customer_service@mail-cmp.niceincontact.com mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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 2706not 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 Calendar Month following the date of the contract, in addition to any fractional part of the initial month.

Thereafter, reports will be on a Monthly 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

Expenditure Category A Percentage of Effort/Hours

(5) Accountable Personal Property

(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 thirty 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.

https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission

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 pre-award 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%20Gover nment%20Property-Appendix%20Q.pdf https://www.cpars.gov/ https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf

CLAUSES INCORPORATED BY FULL TEXT:

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 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 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] PROJECT 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.