75N96025R00002 QA Services 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 83

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 1630 ED local time

(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 5 X I CONTRACT CLAUSES 33

X B SUPPLIES OR SERVICES AND PRICES/COSTS 6 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 9 X J LIST OF ATTACHMENTS 43

X D PACKAGING AND MARKING 11 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 12 X K REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

X F DELIVERIES OR PERFORMANCE 13

X G CONTRACT ADMINISTRATION DATA 16 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 45

X H SPECIAL CONTRACT REQUIREMENTS 22 X M EVALUATION FACTORS FOR AWARD 73

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.

mailto:adam.muhsin@nih.gov

Table of Contents

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 ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.5 RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.6 GUN CONTROL

ARTICLE H.7 OPTION PROVISION

ARTICLE H.8 RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR

FINANCIAL CONFLICTS OF INTEREST

ARTICLE H.9 PUBLICATION AND PUBLICITY

ARTICLE H.10 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.11 HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.12 GOVERNMENT CONTROL OVER UNDELIVERED AND/OR UNPUBLISHED

RECORDS AND DATA

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:

75N96025R00002

3. Issue Date:

21 NOV 2024

4. Set Aside:

[ ] No

[ X] Yes See Part IV Section L

1. Title : Quality Assessment Support 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 30 DEC 2024. 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 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 objective of this requirement is to conduct assessments of the accuracy, consistency, and completeness of various aspects of Division of Translational Toxicology (DTT)/National Institute of Environmental Health

Sciences (NIEHS), or National Toxicology Program (NTP) (products and their components, including data, and provide reports that identify areas in the conduct and documentation of studies that merit attention, correction, or improvement. The activities carried out by this contract will address five requirement areas for quality assessment, including Pathology Tables, Laboratory Reports, Manuscripts, DTT/NIEHS or NTP Reports, Monographs, Literature- Based Products, and Electronic Information (data, data management pipelines, pdf tables, bioinformatics, etc.).

The outputs from this requirement will directly feed into the mission of the Department of Health & Human

Services (HHS) by fostering sound sustained advances in the sciences underlying medicine, public health, and social services. This requirement and these services are necessary to support each of the four focus areas within

DTT: (1) exposure-based research programs, (2) health effects innovation programs, (3) responsive research programs, and (4) strengthening capabilities platforms. This acquisition is for continuing support services for quality assessment that extend beyond the scope and capabilities of internal staff resources.

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.

The 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.

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

a. 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.

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

https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents https://www.ecfr.gov/current/title-45/part-94

(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 Attachment 2 for a list of applicable deliverables reporting requirements.

3. 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_report.doc.

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 Institute 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.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc 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 Institute 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 September 2025 through September 2026.

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 September 2026 - September 2027

Option Year 2 September 2027 - September 2028

Option Year 3 September 2028 - September 2029

Option Year 4 September 2029 - September 2030

Option Year 5 September 2030 - September 2031

Option Year 6 September 2031 - September 2032

Option Year 7 September 2032 - September 2033

Option Year 8 September 2033 - September 2034

Option Year 9 September 2034 - September 2035

Optional 6- month Extension September 2035 - September 2035

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:

Performance

Level of

Effort

(LOE)

Base Period

Performance

Level of

Effort

(LOE)

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.

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 prior to award 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:

Official: Contracting Officer - TBD Email Address____________

Contracting Officer Representative - TBD Email Address ____________ https://www.ipp.gov/

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:

“Quality Assessment Support 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:

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

"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

(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.

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%20G overnment%20Property-Appendix%20Q.pdf 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 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.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 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.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research https://grants.nih.gov/policy/reproducibility/index.htm https://www.ncbi.nlm.nih.gov/pmc/ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html https://publicaccess.nih.gov/ https://publicaccess.nih.gov/

ARTICLE H.6 GUN CONTROL

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

ARTICLE H.7 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 52.217-8, Option to Extend Services/FAR Clause 52.217-9, Option to Extend the Term of the Contract 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 60 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.8 RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST

The Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under NIH contracts, or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site: https://www.ecfr.gov/current/title-45/part-94.

As required by 45 CFR Part 94.4, Responsibilities of Institutions regarding Investigator financial conflicts of interest, each Institution shall:

a. Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this part, and make such policy available via a publicly accessible Web site. If the Institution does not have any current presence on a publicly accessible Web site (and only in those cases), the Institution shall make its written policy available to any requestor within five business days of a request. If, however, the Institution acquires a presence on a publicly accessible Web site during the time of the NIH award, the requirement to post the information on that Web site will apply within 30 calendar days. If an Institution maintains a policy on financial conflicts of interest that includes standards that are more stringent than this part (e.g., that require a more extensive disclosure of financial interests), the Institution shall adhere to its policy and shall provide

FCOI reports regarding identified financial conflicts of interest to the NIH Awarding Component in accordance with the Institution's own standards and within the timeframe prescribed by this part.

b. Inform each Investigator of the Institution's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any NIH-funded contract and at least every four years, and immediately when any of the following circumstances apply:

1. The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

2. An Investigator is new to an Institution; or

3. An Institution finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.

c. If the Institution carries out the NIH-funded research through a subrecipient (e.g., subcontractors, or consortium members), the Institution (awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this part by Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators.

1. If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this part. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee

Institution for disclosing significant financial interests that are directly related to the subrecipient's work for the awardee Institution;

2. Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the

NIH as required by this part;

3. Alternatively, if the subrecipient's Investigators must comply with the awardee Institution's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee

Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this part.

4. Providing FCOI reports to the NIH…