Sol_75N95024R00040.pdf

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: P.L. 99-158 as amended

2. Request for Proposal (RFP) Number:

75N95024R00040

3. Issue Date:

09/20/2024

4. Set Aside:

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

5. Title : Scientific Management and Support to the National Institute of Mental Health (NIMH) Repository and Genomics Resource (NRGR)

6. ISSUED BY:

Office of Acquisitions National Institutes of Health NIDA/NIMH Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive Gaithersburg, MD 20892

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 for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," until 5:00pm local time on October 21, 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 to be submitted via the Electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov as stated in ATTACHMENT 1, "PACKAGING AND

DELIVERY OF THE PROPOSAL FOR USE WITH THE ELECTRONIC CONTRACT PROPOSAL

SUBMISSION (ECPS) WEBSITE." Proposals submitted by facsimile or email will not be accepted.

IF YOUR PROPOSAL IS NOT RECEIVED VIA THE ELECTRONIC CONTRACT PROPOSAL

SUBMISSION (ECPS) WEBSITE BY THE DATE AND TIME OF PROPOSAL SUBMISSION, THEN IT

WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH 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: Sarah Adan

PHONE: 301-480-5422

E-mail: sarah.adan@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

12. QUESTIONS PERTAINING TO THIS RFP

MUST BE SUBMITTED TO SARAH ADAN VIA

EMAIL AT sarah.adan@nih.gov NO LATER THAN 12:00 P.M. (EST) ON October 4, 2024.

Valerie Whipple Contracting Officer National Institute on Drug Abuse Office of Acquisitions https://ecps.nih.gov/ https://www.sam.gov/SAM/ mailto:sarah.adan@nih.gov mailto:sarah.adan@nih.gov

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

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. 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. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Institutional Responsibility Regarding Investigator Conflicts of Interest

11. ROTC Access and Federal Military Recruiting on Campus

12. Past Performance Information

13. 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. Certified Cost or Pricing Data

3. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data. . . . . . . . . . ….98

4. Salary Rate Limitation

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

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/Prices

ARTICLE B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institute of Mental Health Repository and Genomics Resource (NRGR) is a centralized national biorepository funded by the National Institutes of Health (NIH). NRGR provides to the research community DNA, RNA, cell lines, and other biospecimens from large collections of individuals with psychiatric illness along with neurotypical controls. NRGR provides basic demographic and diagnostic data for all biospecimens and genotype, DNA sequence, and gene expression data associated with a subset of biospecimens.

The purpose of this acquisition is to obtain services to sustain, enhance, and enrich NRGR for genetic and cellular studies of psychiatric disorders to facilitate and accelerate the scientific understanding of the genetic risk architecture and basic biology underlying mental disorders. This effort is expected to involve a functionally integrated, multi-disciplinary team that will continue to manage broad sharing of biospecimens and data resources through a single, centralized, national resource to advance basic and translational research in the genetics of mental disorders.

ARTICLE B.2 ESTIMATED COST - OPTION

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

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

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

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

Estimated Cost ($) Fixed Fee

Estimated Cost Plus Fixed Fee

Base period Option Period 1:

Option Period 2:

Option Period 3:

Option Period 4:

Optional Transition In:

Optional Transition Out:

Total Base Period and Options

e. If the Government exercises its option for additional quantities under this contract, pursuant to the option clause referenced in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, the Government's total estimated contract amount will be increased as follows:

Option Period Description of Option Items Quantity

Unit Price ($) for increment of 5%

Total Price of Option if All Quantities

Exercised-

Base period Task Area 2: Optional Up to Additional Quantities in increments of 5%

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

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.

Option Period 1 Task Area 2: Optional Up to Additional Quantities in increments

Option Period 2 Task Area 2: Optional Up to Additional Quantities in increments

Option Period 3

Additional Quantities in increments

Option Period 4

Additional Quantities in increments

Base period Task Area 3: Optional Up to Additional Quantities in increments

Option Period 1

Additional Quantities in increments

Option Period 2

Additional Quantities in increments

Option Period 3

Additional Quantities in increments

Option Period 4

Additional Quantities in increments

Transition In 1 Transition Out 1

SECTION C - Description/Specifications

ARTICLE C.1. Statement of Work

a. Independently and not as an agent of the Government, the Contractor shall 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 September 2024, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.

b. Privacy Act System of Records Number 09-25-0200, Clinical, Basic, & Population-based Research Studies of the NIH is applicable to this contract 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."

a. Technical Progress Reports

Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The report shall be due on the 3rd day of the month. Thereafter, reports shall be due on or before the Working day following each reporting period.

Bi-Annual Progress Summary

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The initial report will be submitted for the first full six months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months.

Monthly and/or quarterly reports will not be submitted the month the semi-annual report is due.

The first report shall be due 6 months after contract start date . Thereafter, reports shall be due on or before the Working day following each reporting period.

Final Report

This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period. A Semi- Annual report shall not be required for the period when the Final Report is due.

Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

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

b. Other Reports/Deliverables

1. Management Plan

A final Management Plan, incorporating any changes or modifications agreed upon by the Government and the Contractor during contract negotiations and the first month of contract performance shall be submitted within one (1) month of contract award.

2. 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.)

3. Section 508 Annual Report

The Contractor must submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's 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.

4. Multiple Principal Investigators Leadership Plan

The Contractor must submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

Reports must be sent to the following addresses as specified:

Deliver to: No. of Copies Contracting Officer Representative (COR): To be specified prior to award One (1) Electronic Copy Contracting Officer: To be specified prior to award One (1) Electronic Copy

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.

https://www.ecfr.gov/current/title-45/part-94 https://www.ecfr.gov/current/title-45/part-94 https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

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 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.

G. 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.

H. 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.

I. 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 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.

J. 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). 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.

K. 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 of 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

If the employee 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.

L. 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 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 are located at: https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html 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 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 https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/HHS-Closeout-Directive-2018.pdf https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html 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 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 Employee Separation Checklist https://ocio.nih.gov/sites/external/files/2024-01/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 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 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 https://ocio.nih.gov/sites/external/files/2024-01/Emp-sep-checklist.pdf 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.

SECTION D - Packaging and Marking

ARTICLE D.1. PACKAGING, MARKING, AND SHIPPING

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

SECTION E - Inspection and Acceptance

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

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Mental Health 6001 Executive Blvd Rockville, Maryland 20852

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

e. 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.

52.246-9 Inspection of Research and Development (Short Form). (APR 1984)

SECTION F - Deliveries or Performance

ARTICLE F.1. PERIOD OF PERFORMANCE - OPTIONS

a. The base period of performance of this contract shall be from March 1, 2025 through February 28, 2026.

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

Option Option Period Option Period 1 3/1/2026 - 2/28/2027 Option Period 2 3/1/2027 - 2/29/2028 Option Period 3 3/1/2028 - 2/28/2029 Option Period 4 3/1/2029 - 2/28/2030 Transition Out 3/1/2030 - 8/31/2030

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 electronically, and in accordance with and by the date(s) specified below:

Item Delivery Schedule

(1) Final Management Plan Within one (1) month of contract award

(2) Monthly Progress Reports (MPS) 3rd day of each month unless it falls during the weekend, then the next business day

(3) Biannual Progress Summaries (BPS) 6 months after contract start date and every 6 months thereafter

(4) Site Visit Plan 4 months prior to the site visit date

(5) Monthly Summary of Sales, if applicable Within 10 business days after the end of each calendar month

(6) Final Report On or before the completion date of the contract Information Technology (IT) Reports

(7) Roster of Employees Requiring Suitability Investigations

Within fourteen(14) calendar days after the effective date of the contract and within seven (7) calendar days of any staffing change.

Must complete and submit the required forms within 30 days of Government’s notification of applicable Suitability Investigations required

(8) Reporting of New Employees Must notify Government within 7 calendar days of the change

(9) Background investigation/Onboarding Documentation

Must be completed prior to employee performing any work under this contract

(10) Reporting of Departing Employees Must notify Government within 7 calendar days of the change

(11) Employee Separation Checklist Must complete checklist within 2days of employee’s exit from contract. Documentation shall be made available upon request.

(12) Commitment to Protect Non- Public Information– Contractor Employee Non-Disclosure Agreement(s)

Must complete prior to any and all employees performing any work under this contract

(13) Training Records and Rules of Behavior In conjunction with contract award and annually thereafter or upon request

(14) Incident Report As soon as possible but no later than 1hour after discovery

(15) Incident and Breach Response Plan Upon request from Government

Administrative Reports

(16) Reporting of Financial Conflict of Interest

Due within 15 calendar days of the contract anniversary date and with the Final Report.

(17) Service Contract Annual Report October 31st following each contract year

(18) Individual Subcontract Report

(ISR)

April 30th and October 30th of each calendar year; and a final report on or before the expiration date of the contract

(19) Summary Subcontract Report (SSR) October 30th of each year

(20) Section 508 Annual Report On or before the anniversary date of the contract award

(21) Contract Closeout Documents Upon/after contract completion

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

Addressee Deliverable Item No Quantity Contracting Officer's Representative 1-16 1 electronic copy Contracting Officer 1-16, 20-21 1 electronic copy Information Systems Security Officer (ISSO) 7-15 1 electronic copy

External submission 17-19 1 electronic copy

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide [TBD] direct labor hours. The labor hours [include/exclude] vacation, holiday, and sick leave. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Period Hours Number of Times Option can be Exercised

Total Possible Hours

Base Period (12 months) 1 Option Period 1 (12 months) 1 Option Period 2 (12 months) 1 Option Period 3 (12 months) 1 Option Period 4 (12 months) 1 Task 2: Optional Up to Additional Quantities (Base Period)

Task 2: Optional Up to Additional Quantities (Option 1 Period)

Task 2: Optional Up to Additional Quantities (Option 2 Period)

Task 2: Optional Up to Additional Quantities 10(Option 3 Period)

Task 2: Optional Up to Additional Quantities (Option 4 Period)

Task 3: Optional Up to Additional Quantities (Base Period)

Task 3: Optional Up to Additional Quantities (Option 1 Period)

Task 3: Optional Up to Additional Quantities (Option 2 Period)

Task 3: Optional Up to Additional Quantities (Option 3 Period)

Task 3: Optional Up to Additional Quantities (Option 4 Period)

Transition In (Base Period) 1 Transition Out (6 Months) 1

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.

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984) is applicable to this contract.

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

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 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 Principal Investigator

TBD Senior Project Manager

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

A. Invoice Submission

1. 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.

2. The Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform(IPP) at https://www.ipp.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice shall be transmitted as an attachment via email https://www.ipp.gov/ to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

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

Official: Contracting Officer

Name- To be specified prior to award Email Address- To be specified prior to award

Contracting Officer Representative

Name- To be specified prior to award Email Address- To be specified prior to award

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.

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institute of Drug Abuse (NIDA) .

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

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

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

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

f. The Contract Title is: Scientific Management and Support to the National Institute of Mental Health (NIMH) Repository and Genomics Resource (NRGR)

g. Contract Line Items as follows:

Line Item # Line Item Description

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

5. 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. 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.

ARTICLE G.5. INDIRECT COST RATES

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

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

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

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

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

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

a. Electronic Access to Contractor Performance Evaluations

Contractors may…