RFP package.pdf

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95024R00025

“Clinical Coordinating Center for NIDA’s Clinical Trials Network”

Issued by:

Joshua T. Lazarus, Contracting Officer NIDA Section, Contracts Management ranch Red Office of Acquisition, NIDA C/O NIH Mail Center NIDA 3WFN MSC 6023– Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

DATE ISSUED: Tuesday, December 27, 2023

PROPOSAL DUE DATE: Friday, February 9, 2024 3:00 P.M. Eastern Time

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00025 titled “Clinical Coordinating Center for NIDA’s Clinical Trials Network”.

Please refer to Section M for mandatory criteria. Additionally, all offerors must be REGISTERED and have an ACTIVE System for Award Management "http://www.sam.gov/" (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-7 System for Award Management and FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

NIDA expect to award an Indefinite Delivery Indefinite Quantity (Task Order) contract with individually negotiated task orders over a five-year period of performance. Cost reimbursement and/or firm fixed price task orders are expected to be awarded concurrently with and after contract award. All funding will be made through issuance of task orders and will be dependent on program needs and funding availability. The contract will contain a minimum of $5,000 (minimum funded by task orders concurrent with award) and a maximum of $49,500,000 (maximum) for the entire contract period.

You must respond with technical and pricing proposals for the entire project and total period of performance.

General

Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 2 is a "Proposal Intent Response Sheet." Please complete this form and return it to polina.klimenkova@nih.gov by January 20, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Requests for Information (RFIs) Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. RFIs must be submitted on or before 3:00 p.m. on Monday, January 15, 2023. RFIs may be submitted by e-mail to polina.klimenkova@nih.gov with the subject line “RFI – RFP 75N95024R00025”.

The Business Proposal

The Business Proposal must contain a detailed breakdown of costs by task, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. Please utilize the Breakdown of Proposed Estimated Costs and Excel spreadsheet contained in Attachment 10.

A completed Form NIH-2043, “Proposal Summary and Data Record” must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal.

See Section L.2.c. for additional detail. The

Technical Proposal

Offerors shall complete and attach the “Technical Proposal Cover Sheet” to their technical proposal. Be sure to list all professional personnel and organizations named in the proposal who have any role in the proposed work including staff, subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be shown for each person named. If needed, additional sheets may be included using the same format. This information is vital to ensure that no conflicts of interest exist with the review committee members.

Format and content requirements for the Technical Proposal are detailed in Section

L.2.b. Submitting a Proposal http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than Friday February 9, 2024, 3:00 P.M. Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner.

Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly. Additional instructions on how to submit a proposal via eCPS can be found at https://ecps.nih.gov/home/howto and in Attachment 01.

All notices related to this solicitation will be posted on Sam.gov (https://www.sam.gov) as well as the NIDA Contracts Home Page https://nida.nih.gov/funding/nida-office-acquisitions-contracting If you would like to receive e-mail notifications of updates to this solicitation, please register with SAM.gov.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints.

The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers

This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The National Institute on Drug Abuse appreciates your interest in this RFP and looks forward to receipt of your proposal. Requests for any information concerning this RFP should be directed to Polina Klimenkova, NIDA Section, Contracts Management Branch Red who may be reached by e-mail at polina.klimenkova@nih.gov.

Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Josh Lazarus, Contracting Officer NIDA Section, CMB Red

Office of Acquisitions, NIDA/NIH

Enclosure https://ecps.nih.gov/ https://ecps.nih.gov/home/howto https://ecps.nih.gov/home/howto https://www.sam.gov/ https://nida.nih.gov/funding/nida-office-acquisitions-contracting https://nida.nih.gov/funding/nida-office-acquisitions-contracting mailto:polina.klimenkova@nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321 as amended

2. Request for Proposal (RFP) Number:

75N95024R00025

3. Issue Date:

December 27, 2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Coordinating Center for NIDA's Clinical Trials Network

6. ISSUED BY:

NIDA Section, Contracts Management Branch Red C/O NIH Mail Center, NIDA 3WFN MSC 6023 16071 Industrial Drive - Dock 11 Gaithersburg, MD 20877 (20892 for USPS)

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 PM local time on February 9, 2024. Offers will be valid for 18 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 ATTACHMENT 1, "Packaging and Delivery ofthe Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website." Proposals submitted by any other means such as facsimile, hard copy or e-mail will not be accepted.

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 Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) when submitting a proposal and continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation.

Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration.

11. FOR INFORMATION CALL: Polina Klimenkova, Contract Specialist

PHONE: 301-443-6677

e-MAIL: polina.klimenkova@nih.gov

Josh Lazarus/Contracting Officer

RFP Number : 75N95024R00025

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

a. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

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10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. Certification Regarding Tax Matters, FAR 52.209-12 (Oct 2020)

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

16. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT

PROCUREMENTS

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. PAST PERFORMANCE FACTOR

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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 IF NECESSARY 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.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective of this contract is for the Contractor to provide bio-medical and behavioral research resources and clinical research coordinating services to support the NIDA Clinical Trials Network (CTN) in its goal of conducting multi-site clinical trials to test the effectiveness of new science-based drug abuse treatments in community settings.

ARTICLE B.2. PRICES/COSTS

1. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $5,000 (minimum) and not more than a total of $49,500,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract. Total compensation will be based on the combined negotiated task orders.

2. For cost reimbursement Task Orders, the fixed fee for individual task orders will be negotiated by task order. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work or the percent of total effort expended), as determined by the Contracting Officer, and shall be subject to the withholding provision 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. Payment of fixed fee shall not be made in less than monthly increments.

3. The costs set forth in this ARTICLE will cover the five-year contract ordering period.

4. The Government will issue Task Orders based on the work described in SECTION C of this contract.

5. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.3. ESTIMATED COST - OPTION

1. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, individual Task Orders consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

2. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item, FAR Clause 52.217-8, Option to Extend Services and FAR Clause 52.217-9 Option to Extend the Term of the Contract set forth in ARTICLE I.3. and ARTICLE I.4. of this contract, the Government may,within individual Task Orders and as specified by unilateral contract modification, require the Contractor to perform the Option Period( s)

- 5 -and Option Quantities specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/ these option( s), notice must be given 15 calendar days before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The estimated cost plus fixed fee of the task order will be increased as set forth in paragraph 3., below.

3. 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:

Description of Option Item( s) - or- Option Service( s)

Estimated Cost Fixed Fee Estimated Cost plus Fixed Fee

Option Quantity Task A: Administrative and Concept Support Services (This option may be exercised 5 times during each contract year.)

Option Quantity Task B: Research Protocol Development and Support (This option may be exercised 5 times during each contract year.)

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; and 13) Research Funding.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

DEA Registration

For the duration of the contract, the Contractor agrees to maintain, at no direct cost to this contract, the required DEA Research or Chemical Analysis Registrations (Schedule I, Schedules II to V) for working with scheduled drugs.

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. NIDA reserves the right to have the contracted services in this contract benefit NIDA and other components of NIH.

[Remainder of Page Intentionally Left Blank]

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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).

b. The applicable Privacy Act System of Records Number 09-25-0200 shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format as specified in Section F of the RFP.

All electronic reports submitted 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: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Technical Progress Reports

1. 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.

The Contractor will meet (by conference call or face-to-face) with NIDA's Contracting Officer's Representative (COR) and designee(s) once per week during the first year of the contract, and at least once every two weeks thereafter.

The Contractor shall deliver a project plan to identify the tasks, schedules, and milestones. In addition to the reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with F.1. Deliveries of this contract:

1. Technical Progress Reports

Quarterly Progress Report:

Quarterly progress reports shall be brief reports:

● work accomplished during the period;

● progress on all trials/ projects

● planned activities for the upcoming period; and http://www.hhs.gov/web/508/index.html

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● a description of any problems experienced or anticipated in the upcoming period.

One (1) copy of this report will go to the COR and one copy to the Alternate COR within ten (10) business days following the end of each contract quarter. The first reporting period consists of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each three month quarter.

Annual Progress Report.

This report shall include a summation of the work accomplished under the contract for the period covered. An annual report will not be required for the period when the Final Report is due. A quarterly report shall not be submitted when an annual report is due.

Task Order Report

This report shall include a summation of the work accomplished under issued task orders.

This will cover the entire period of performance for that task. It should include highlights, issues and their resolution, recommendations or lessons learned, etc.

Final Report

This report is to include a summation of the work performed for the entire contract period of performance. The Final Report shall be submitted in accordance with the Deliveries article of Section F of this contract . An annual report will not be required for the period when the Final Report is due.

2. 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: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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2. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

See ARTICLE H.14. for a description of required Information Security deliverables.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract to the Contracting Officer.

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.

http://www.iedison.gov

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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.

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SECTION E - INSPECTION AND ACCEPTANCE

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

2. For the purpose of this SECTION, the Contracting Officer's Representative (COR), whose position is described in Section G, is the authorized representative of the Contracting Officer.

3. Inspection and acceptance will be performed at:

National Institute on Drug Abuse National Institutes of Health c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

[Remainder of page intentionally left blank]

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The estimated ordering period of this contract shall be from August 2, 2024 through August 1, 2029. The period of performance for each task order shall be specified in the respective task order.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Description Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

1. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

(1) Project Plan - Tasks, schedules, milestones (kick-off metting)

2 electronic Within 2 weeks after award

(2) Quarterly Progress Reports

2 electronic Within 10 business days following the end of the each contract quarter

(3) Annual Progress Report 2 electronic Within 15 business days following the end of each contract year

(4) Final Progress Report 2 electronic On or before contract expiration

(5) Task Order Report 2 electronic On or before the expiration of each Task Order

(6) Summary of Salient Results

2 electronic On or before contract expiration

(7) Annual Utilization Report 1 electronic Within 15 calendar days following the end of each contract year

(8) Final invention Report 1 electronic On or before contract expiration.

(9) System Security Plan (SSP) with system architecture diagram/ details

1 electronic See ARTICLE H.14

(10) Security Assessment Plan (SAP) & Security Assessment Report (SAR)

1 electronic See ARTICLE H.14

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Item Description Quantity Delivery Schedule

(11) Plan of Actions & Milestones (POA&M) and updates

1 electronic See ARTICLE H.14

(12) Privacy Threshold Analysis (PTA) / Privacy Impact Assessment (PIA)

1 electronic See ARTICLE H.14

(13) E-Authentication Threshold Analysis (ETA) / EAuthentication Risk Assessment (ERA)

1 electronic See ARTICLE H.14

(14) Incident Response Report (as incidents or breaches occur)

1 electronic See ARTICLE H.14

(15) Contingency Plan (CP) and Contingency Plan Test (CPT) Report

1 electronic See ARTICLE H.14

(16) Vulnerability Scanning Reports

1 electronic See ARTICLE H.14

(17) Configuration Baseline & Configuration Management Plan

(CMP)

1 electronic See ARTICLE H.14

(18) Non-Disclosure Agreements

1 electronic Prior to performance of any work under this contract

(19) Reporting of Financial Conflict of Interest

(FCOI)

1 electronic See Article C.2(b)(1) for details.

(20) Site visit Reports (if applicable)

1 electronic 14 days following a site visit.

(21) FIPS-199, Standards for Security Categorization

1 electroinc See ARTICLE H.14

In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items: Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property); standard forms 1428 and 1429 (if applicable);

settling all subcontract costs and any issues thereunder; subcontracting compliance reports for all years to the eSRS;

final patent and royalty reports; Contractor's release of claims, i.e. Contractor's closing statement; the Contractor's Assignment of Refunds, Rebates and Credits; and a final invoice or completion voucher (marked final).

2. The above items shall be addressed and delivered to:

Addressee Deliverable Item No. Quantity

Contracting Officer 1-21 1 electronic

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Addressee Deliverable Item No. Quantity

Contracting Officer's Representative 1-6 1 electronic

Information Systems Security Officer

(ISSO)

9-17, 21 1 electronic

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) 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. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

TBD

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 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 designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 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 individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

1. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

2. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from the Contractor. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions; and

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

3. Ordering Process.

1. The Contractor will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. The Contractor will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order.

Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

● Understanding of the requirements;

● Experience and capability on similar tasks;

● Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies.

● Procedures for assuring quality of work, products, and deliverables;

● Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

● Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

● Cost/Price to perform the task order.

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4. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price However, each TORFP will specify how the award decision will be made. The Government may conduct discussions prior to awarding Task Order or award a Task Order without discussions. The Government reserves the right to cancel aTORFP any time prior to Task Order Award.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

The Contractor must submit a copy of the electronic invoice to the following Approving Official and Contracting Officer Representative:

Approving Official: Contract Specialist/Contracting Officer

Name- TBD Email Address-

Contracting Officer Representative

Name- 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:

1. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Section, Contracts Management Branch Red.

2. 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. 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.

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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.

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

4. 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.

5. The Contract Title is:

Clinical Coordinating Center for NIDA's Clinical Trials Network

g. Contract Line Items will be designated by Task Order.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. 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.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (Nov 2021)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

ARTICLE G.6. 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

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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:HYPERLINK 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.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. 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 the contract anniversary date.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted 14 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.

2. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. RESEARCH AND DEVELOPMENT DATA IN ELECTRONIC RESEARCH

ADMINISTRATION (eRA) SYSTEM

The Contractor shall enter and/or update research and development data fields at the contract project level in Electronic Research Administration (eRA) system within fifteen (15) calendar days of being notified by the eRA system. [The notification will come in the form of an eRA Commons system-generated email, sent to the Contractor's registered user(s) under the contract.]

The eRA system website may be accessed at: https://public.era.nih.gov/commonsplus/public/login.era?

TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommonsplus. Please note that if your organization does not currently have an account in eRA Commons, you will first need to register your organization at https:// public.era.nih.gov/commonsplus/public/registration/initRegistration.era. Once your organization is registered, your signing official is then able to create new eRA system user accounts (such as for a Project Director/Principal Investigator). For information on how to create/manage accounts, using the Account Management System (AMS) in eRA system, please refer to: https://www.era.nih.gov/register-accounts/create-and-edit-an-account.htm.

ARTICLE H.2. 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.3. 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 http:// www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate. More information is available at http://grants.nih.gov/reproducibility/index.htm, including FAQs and a General Policy Overview.

ARTICLE H.4. 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 research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.