RFP -75N95024R00013.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 102-321

2. Request for Proposal (RFP) Number:

75N95024R00013

3. Issue Date:

2/26/2024

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : The NIH National NeuroHIV Tissue Consortium - New Clinical Site

6. ISSUED BY:

NIDA Office of Acquisition National Institutes of Mental Health National Institutes of Health 16071 Industrial Drive Gaithersburg, MD 20877

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 5PM (EST) local time on 4/10/2024. ALL QUESTIONS PERTAINING TO THIS RFP MUST BE SUBMITTED TO KRISTINA JENKINS VIA EMAIL (SEE ITEM NO. 110 NO LATER THAN 12:00 P.M. (EST) ON 3/11/2024.

Offers will be valid for 120 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

OF THE PROPOSAL." 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 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) 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: Kristina Jenkins, Contracting Officer (primary)

PHONE: 1-301-402-7464

e-MAIL: kristina.jenkins@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Christine Frate Contracting Officer, (secondary) NIDA Office of Acquisition christine.frate@nih.gov, 301-443-3846 https://www.sam.gov/SAM/ mailto:kristina.jenkins@nih.gov mailto:christine.frate@nih.gov

RFP Number : 75N95024R00013

- 3 -

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

ARTICLE H.4. CERTIFICATE OF CONFIDENTIALITY

ARTICLE H.5. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

ARTICLE H.7. POSTING CLINICAL TRIAL INFORMED CONSENT FORMS TO CLINICALTRIALS.GOV

PART II - 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

1. GENERAL INFORMATION

a. NAICS CODE AND SIZE STANDARD

b. TYPE OF CONTRACT AND NUMBER OF AWARDS

c. LEVEL OF EFFORT

d. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. CONCEPT REVIEW

h. PREPARATION COSTS

i. 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

- 4 -

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

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

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. 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. Cost and Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

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. HUMAN SUBJECT EVALUATION

4. EVALUATION OF OPTIONS

5. EVALUATION OF DATA SHARING PLAN

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

8. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

9. PAST PERFORMANCE FACTOR

- 5 -

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.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to establish a new National NeuroHIV Tissue Consortium (NNTC) Clinical site as a critical resource for catalyzing high priority research in NeuroHIV (CNS complications in people with HIV), including studies to understand the mechanisms of HIV neuropathogenesis, aging with long-term HIV and ART, and research towards an HIV cure. The NNTC clinical site shall collect, store, and provide clinical data and well characterized biological specimens, including antemortem/ postmortem tissue from study volunteers and/or organ donors with HIV as well as HIV-negative controls.

It is anticipated that one contract clinical site will be established from this RFP. The establishment of a new NNTC clinical site is necessary to ensure geographic diversity; therefore, sites in the southern and midwestern United States are actively being sought.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. 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 will be increased as follows: TBD

Estimated Cost

Base Period

Option Period One (1)

Option Period Two (2)

Option Period Three (3)

Total [Base Period and Option(s)]

- 6 -

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

- 7 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. [DESCRIPTION-SPECIFICATION-WORKSTATEMENT-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, dated 02/05/2024, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and 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 Representative (COR).

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."

Any paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

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 only, it is estimated that the required electronic version(s) will be required as follows:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

Summary of Salient Results https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents

- 8 -

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

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

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

94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

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

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

2. Source Code and Object Code

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

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

INFORMATION AND/OR PHYSICAL SECURITY

A. Assessment and Authorization (A&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor must conduct the A&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

B. A&A Package Deliverables - The Contractor (and/or any subcontractor) must provide an A&A package within

30 days of contract award to the CO and/or COR. The following A&A deliverables are required to complete the A&A package.

C. System Security Plan (SSP) - due within 30 days after contract award. The SSP must comply with the NIST

SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP must be consistent with and detail the approach to IT security contained in the Contractor's https://www.ecfr.gov/current/title-45/part-94

- 9 -bid or proposal that resulted in the award of this contract. The SSP must provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor must update the SSP at least annually thereafter.

D. Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment must be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by Contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

E. Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) must have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party must review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor must address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

F. Plan of Actions and Milestones (POA&M) - due 30 days after contract award. The POA&M must be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All findings/ weaknesses must be documented in the POA&M and remediated/mitigated from the date the weaknesses are formally identified and documented by the timelines below:

• Critical within 30 days;

• High within 60 days;

• Medium within 1 year; and

• Low within 1 year.

The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, must be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M must be updated at least quarterly.

G. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, must test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

Thereafter, the Contractor must update and test the Contingency Plan at least annually.

H. E-Authentication Questionnaire - The contractor (and/or any subcontractor) must collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a

- 10 -system using E-auth TA/E-auth RA methods must follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

I. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at: https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx and the link to access the tool is found at: https://pdt.nbis.mil/.

The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[X] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

J. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster must be submitted to the COR and/ or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx https://ors.od.nih.gov/ser/dpsac/administrators/onboarding-new-staff/Pages/position-designation-tool.aspx https://pdt.nbis.mil/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

- 11 -

a. If the Contractor is filling a new position, the Contractor must provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

b. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor must complete and submit the required forms within 30 days of the notification.

c. The Contractor must notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

d. All contractor and subcontractor employees must comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

e. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor must ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

f. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

g. The Contractor must include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

h. The Contractor must direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

i. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor must return all identification badges to the Contracting Officer or designee.

K. CONTRACT INITIATION AND EXPIRATION

a. General Security Requirements- The Contractor (and/or any subcontractor) must comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the Contractor must follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Directive (2018) located at: https://oamp.od.nih.gov/ sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf. HHS EA requirements located at: https://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf and NIH EA requirements are located at: https://ocio.nih.gov/PM/Pages/EPLC.aspx.

b. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system development and provide system documentation at designated intervals ( specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor ( and/ or any subcontractor) must provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/ or COR to certify http://www.hhs.gov/sites/default/files/eplc-policy-dec-2016.pdf https://ocio.nih.gov/PM/Pages/EPLC.aspx

- 12 -that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

d. Notification - The Contractor ( and/ or any subcontractor) must notify the CO and/ or COR and system ISSO within fifteen days before an employee stops working under this contract.

e. Contractor Responsibilities Upon Physical Completion of the Contract- The Contractor (and/ or any subcontractors) must return all government information and IT resources ( i.e., government information in non- government- owned systems, media, and backup systems) acquired during the term of this contract to the CO and/ or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor- owned systems, including backup systems and media used during contract performance, in accordance with HHS and/ or NIH policies.

f. The Contractor ( and/or any subcontractor) must perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/ acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation must be made available to the CO and/ or COR upon request.

g. Contractor Non- Disclosure Agreement (NDA)- Each Contractor ( and/ or any subcontractor) employee having access to non- public government information under this contract shall complete the NIH non- disclosure agreement: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf, as applicable. A copy of each signed and witnessed NDA must be submitted to the Contracting Officer ( CO) and/ or CO Representative ( COR) prior to performing any work under this acquisition.

h. Vulnerability Scanning Reports - The Contractor must report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report must be submitted under a separate cover on monthly basis.

i. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment ( to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

i. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract. The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

ii. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify

- 13 -the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

iii. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information.

iv. Cooperate with inspections, audits, investigations, and reviews.

4. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: https://www.hhs.gov/sites/ default/files/web/508/contracting/technology/section_508_annual_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, 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.

Contracting Officer National Institutes of Health NIDA Office of Acquisition

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/

- 14 -

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.

ARTICLE D.1. PACKAGING

The Contractor shall have the appropriate shipping licenses and permits from local, State, Federal and International authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable.

Refer to Attachment 3, Statement of Work for additional shipping details.

- 15 -

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 Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

The inspection and acceptance of biospecimens will be performed at the Clinical Site.

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 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

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

- 16 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The base period of performance of this contract shall be from September 9, 2024, through September 8, 2025.

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

Option Option Period

Option Period One September 9, 2025 – September 8, 2026

Option Period Two September 9, 2026 – September 8, 2027

Option Period Three September 9, 2027 – September 8, 2028

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final 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 following items in accordance with the stated delivery schedule:

a. 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 [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Quantity Delivery Schedule

(1) Standard Operating Procedures

(SOP)

One (1) electronic copy

Due within sixty (60) calendar days after contract award and in accordance with the Statement of Work.

(2) Quality Management Program

(QMP)

One (1) electronic copy

Due within sixty (60) calendar days after contract award and in accordance with the Statement of Work.

(3) Laboratory Information Management System (LIMS)

One (1) electronic copy

Due within sixty (60) calendar days after contract award in accordance with the Statement of Work.

(4) Quarterly Technical Progress Reports

One (1) electronic copy

Due quarterly, within fifteen (15) calendar days following completion of the contract quarter in accordance with the Statement of Work.

(5) Annual Technical Progress Reports

One (1) electronic copy

Due quarterly, within twenty (20) calendar days following the end of the contract year in accordance with the Statement of Work

(6) Final Technical Report One (1) electronic copy

Due by completion date of the Contract in accordance with the Statement of Work.

(7) Initial Transition Plan One (1) electronic copy

Due sixty (6) months after contract award and in accordance with the Statement of Work.

- 17 -

Item Description Quantity Delivery Schedule

(8) Annual Transition Plan One (1) electronic copy Due annually with Annual Technical Progress Report and with the Final Technical Progress Report.

(9) Final Transition Plan One (1) electronic copy

Due at the request of the COR and before the end of the contract in accordance with the Statement of Work.

(10) Summary of Salient Results Due in accordance with Section C.2 of the contract.

(11) Roster of Employees requiring suitability

One (1) electronic copy

Onboarding- Prior to performing any work on behalf of NIH/NIMH, and monthly thereafter. Offboarding documentation, equipment and badge when leaving contract within 3 business days

(12) Contractor Non-Disclosure Agreement (NDA)

One (1) electronic copy

Prior to performing any work under this acquisition.

(13) Section 508 Annual Report One (1) electronic copy

Due annually with Annual Technical Progress Report and with the Final Technical Progress Report.

(14) Small Business Subcontracting Report

Submission at http:// www/esrs.gov

Due semi-annually, on or before April 30th (individual report) and on or before October 30th (individual and summary reports) in accordance with Section H. of the contract.

(15) Government Property Report One (1) electronic copy

Due annually with Annual Technical Progress Report and with the Final Technical Progress Report.

(16) Invention Reporting Requirement

One (1) electronic copy

Due annually with Annual Technical Progress Report and with the Final Technical Progress Report.

(17) Financial Conflict of Interest

(FCOI)

One (1) electronic copy

Due in accordance with Section C.2 of the contract.

(18) Privacy Impact Assessment

(PIA)

One (1) electronic copy

Due 60 days after completion of the Privacy Threshold Analysis (PTA) in accordance with Section H.13 of the contract.

(19) Signed Rules of Behavior (ROB) One (1) electronic copy

Initiation of contract and at least annually thereafter.

(20) Incident and Breach Response Plan

One (1) electronic copy

Upon request from Government.

(21) NIH Form NH270 Certification of Sanitization of Government and Government Activity- Related Files, Information, and Devices.

One (1) electronic copy

NIH/NIMH requires NIH Form NH270 Certification: Removal of Data and Software

(22) Form NIH 2706, Financial Report of Individual Project/Contract

One (1) electronic copy

Due in accordance with Section G.2 of the contract.

- 18 -

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

Addressee Deliverable Item No Quantity Contracting Officer’s Representative (COR) 1-13, 15,16,17,18,19,20,21 One (1) electronic copy

Contracting Officer (CO) 1-22 One (1) electronic copy

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide 11,378 direct labor Hours . The labor Hours Include vacation, holiday, and sick leave. These labor Hours Exclude subcontractor labor Hours .

It is estimated that the labor Hours are constituted as specified below and will be expended approximately as follows:

Labor [HOURS]

Labor Category Base Period Option Period One

Option Period Two

Option Period Three

Professional (Principal Investigator, Co- Investigator(s))

978 / 47% 978 / 47% 978 / 47% 978 / 47%

Other Professional and Support

10,400 / 500% 10,400 / 500% 10,400 / 500% 10,400 / 500%

Totals 11,378 / 547% 11,378 / 547% 11,378 /547% 11, 378 / 547%

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 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.

https://www.acquisition.gov/?q=browsefar

- 19 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

To be specified prior to 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 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 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

To be specified prior to award

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission

- 20 -procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

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.4. INVOICE SUBMISSION

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

b. 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. CONTRACT FINANCIAL REPORT

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

b. Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled " PREPARATION INSTRUCTIONS," all columns A through J, shall be completed for each report submitted.

c. The first financial report shall cover the period consisting of the first full 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)

- 21 -

Expenditure Category A Percentage of Effort/Hours

(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.6. 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…