2. RFP_75N95024R00004_STSS2.5.pdf

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This is a Request for Proposal (RFP) from the Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse seeking Scientific and Technology Support Services (STSS) for the National Center for Advancing Translational Sciences (NCATS). The contractor shall provide scientific and technology support for NCATS systems used in intramural research and development projects and programs aimed at advancing NCATS' mission. The RFP anticipates a one-year ordering period from February 1, 2024 through January 31, 2025 with a minimum value of $10,000 and maximum of $49 million to be awarded as an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Task orders will be issued on a firm-fixed price or cost reimbursement basis. Proposals are due by 11:00 AM local time on January 18, 2024. The primary place of performance is the Rockville-Bethesda, Maryland area.

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RFP Number: 75N95024R00004

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal

(RFP) Number:

75N95024R00004

3. Issue Date: December 19, 2023

4. Set Aside:

[×] No

[ ] Yes See Part IV Section L

5. Title: NCATS Scientific and Technology Support Services (STSS)

6. ISSUED BY:

Office of Acquisition National Institute on Drug Abuse National Institutes of Health

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposals for

Use with the NIH electronic Contract

Proposal Submission (eCPS) Website,"

ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 11:00 AM local time (eastern standard time) on January 18, 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." THE OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the NIH electronic Contract Proposal Submission (eCPS) Website. IF YOUR PROPOSAL IS NOT RECEIVED BY

THE eCPS WEBSITE AT THE TIME SPECIFIED 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 and active in the System for Award Management (SAM) when submitting an offer or quotation and shall continue to be actively registered until time of award, during performance, and through final payment of any contract resulting from this solicitation. Offerors must access the System for Award Management

(SAM) at https://www.sam.gov/.

11. FOR INFORMATION: Nick Niefeld

PHONE: (301) 827-2094

E-MAIL: nick.niefeld@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is 9:00 AM local time (eastern standard time) on December 28, 2023. ALL QUESTIONS

MUST BE IN WRITING AND SUBMITTED VIA EMAIL to

Contract Specialist, Nick Niefeld (nick.niefeld@nih.gov).

Responses to Offeror questions shall be provided via an amendment to the RFP posted in SAM.gov on or around January

5, 2024.

KJ Shaikh

Contracting Officer

Office of Acquisition

National Institute on Drug Abuse

National Institutes of Health https://www.sam.gov/ mailto:nick.niefeld@nih.gov mailto:nick.niefeld@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. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

b. TECHNICAL PROPOSAL INSTRUCTIONS

c. BUSINESS PROPOSAL INSTRUCTIONS

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. 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, IF NECESSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED

CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

[Remainder of Page Intentionally Left Blank]

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Center for Advancing Translational Sciences (NCATS) which is sometimes referred to herein this plan as the Center is mission focused to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS is improving health through smart science. The goal is to get more treatments to more patients more quickly. The Center develops, demonstrates, and disseminates innovations that reduce, remove or bypass system-wide bottlenecks in the translational process. NCATS focuses on what is common across diseases and collaborates with other government agencies, including other National Institutes of Health (NIH) Institutes and Center's; industry; academia; and patient support organizations.

The Center requires Scientific and Technology Services Support (STSS) for which the contractor shall provide scientific and technology support for the numerous NCATS systems (both physical and virtual) that are used in support of NCATS ongoing and new intramural research and development (R&D) projects and programs that are aimed at advancing the above-mentioned scientific mission of the Center.

ARTICLE B.2. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $10,000.00 (minimum) nor more than a total of

$49,000,000.00 (maximum) for successful performance of this contract.

b. The costs/prices set forth in this ARTICLE will cover the contract ordering period of one (1) year anticipated to begin on 2/1/2024 through 1/31/2025.

c. As necessary, NCATS will issue Task Orders for the Contractor to perform any or all of the Performance

Activities in the Statement of Work (SOW). It is anticipated that these task orders will be either firm-fixed price time & material or cost reimbursement.

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

e. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

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.

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer:

1. Subcontracts

It is the responsibility of the prime contractor to ensure that the FAR and contract required flow-down clauses are included in any subcontract agreement.

2. Non-Personal Services and Inherently Government Functions

Contractor employees performing services under this order will be managed, directed and supervised at all times by management, supervisory personnel of the Contractor. Contractor employees will perform independent of, and without the supervision of, any Government official. Actions of Contractor employees may not be interpreted or implemented in any manner that results in any Contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR).

The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

Specifically:

a. Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the

Contractor's Project Manager. No Contractor employee will be directly supervised by the

Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the

Government and any Contractor employee, the Contractor shall promptly notify the Contracting

Officer of this communication or action.

b. Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government

Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way to change the contract and that if the other Contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the

Contracting Officer.

c. The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this ARTICLE. Nothing in this ARTICLE shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this

ARTICLE shall be included in all subcontracts at any tier.

3. Travel Costs

The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations(FAR) 31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs, and the Federal Travel Regulations.

4. Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:

Contract Number: [To be specified prior to award]

5. Primary Place of Performance

Per the Statement of Work, the primary place of performance is the Rockville-Bethesda, Maryland area.

National Institutes of Health National Center for Advancing Translational Sciences 6701 Democracy Boulevard Bethesda, MD 20817

6. Information Security

The Contractor shall satisfy IT Security Requirements at both the Task Order level and the contract level (as specified in Section H).

7. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the

Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

8. Core Hours

The Contractor shall provide support Monday through Friday during normal working hours. Specific hours are at the discretion of the Contractor; however, the Contractor must provide coverage between the core hours of 9:00 a.m. through 3:00 p.m. Coverage shall be coordinated with the COR, and the COR may require Contractor presence between 7 am and 6 pm. Services under this task order will not be required on Federal holidays or when

NIH is closed. The Contractor must have staff available for incident or emergency response within 1 hour at all times.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, attached hereto, and made a part of this Solicitation (See SECTION J -

List of Attachments). Contractors are required to be able to perform the entire Statement of Work.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html and at:

https://www.section508.gov/create/documents, "Create Accessible Documents."

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract/task order 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 for the parent contract award and at the task order level. Note: 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 one (1) electronic version of the following report(s) will be required as follows*:

[×] Monthly

[ ] Quarterly

[ ] Semi-Annually

[× ] Annually

[ ] Annually (with a requirement for a Draft Annual Report)

[ ] Final - Upon final completion of the contract

[×] Final - Upon final completion of the contract/task orders (with a requirement for a Draft Final Report)

*Ad hoc reporting may be required.

b. Other Reports/Deliverables

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

INFORMATION AND/OR PHYSICAL SECURITY

A. 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 generally apply to this solicitation/ contract/task orders:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall http://www.hhs.gov/web/508/index.html https://www.section508.gov/create/documents undergo a Suitability Determination and Background Investigation (MBI).

[×] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a

Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a

Suitability Determination and National Check and Inquiry Investigation (NACI).

B. 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

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.

C. 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-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 forms/HHS-Closeout-Directive-2018.pdf . HHS EA requirements 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 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 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 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 https://ocio.nih.gov/PM/Pages/EPLC.aspx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf 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 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.

1. 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.

2. Service Contract Reporting Requirements

The Contractor shall report on services performed as required by FAR Clause 52.204-14, Service Contract Reporting Requirements.

3. Subcontract Reporting

The Contractor shall submit Individual Subcontract Reports and Summary Subcontract Reports as required by the SUBCONTRACTING PROVISIONS Article in SECTION H of this contract and the DELIVERIES Article in SECTION F of this contract.

https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The

Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the [To be specified prior to award] is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institutes of Health National Center for Advancing Translational Sciences 6701 Democracy Boulevard Bethesda, MD 20817

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

The Government reserves the right to an Inspection period of calendar days, unless a different time period is stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

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 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

FAR Clause 52.246-6 Inspection-Time-and-Material and Labor-Hour (May 2001)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE- ORDERING PERIOD

The anticipated ordering period of this IDIQ Contract shall be from February 1, 2024 through January 31, 2025 (1-year).

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:

Item

Number

Description Delivered to Due Date

1. Monthly Progress Reports COR & CO Submitted with monthly invoice and no later than 15 business days after the start of the month (task order level)

2. Annual Report COR & CO No later than 15 business days after each year of the contract/task order period of performance

3. Final Report with Transition

Plan

COR & CO Transition Plan submitted on an as needed basis to transfer Contractor requirements to a follow-on Contractor.

Final Report due on or before completion date of contract (contract/task order)

4. Individual Subcontracting

Report (ISR)

Submitted electronically at www.esrs.gov with

Contracting Officer listed as contact

April 30 and October 30 of each year of the contract period of performance

5. Summary Subcontract Report

(SSR)

Submitted electronically at www.esrs.gov with

Contracting Officer listed as contact

October 30th of each year of the contract period of performance

6. Position Sensitivity

Designations for Suitability

Determination Reporting

Requirements

COR & CO Within 14 days of the effective date of the contract and 15 days following the addition or change of staff http://www.esrs.gov/

7. Roster of personnel with their defined roles and responsibilities

COR & CO Within 30 Days of the effective date of this contract.

8. Contractor Employee Non-

Disclosure Agreement (NDA) COR & CO Prior to performing any work on behalf of NIH.

9. Signed Rules of Behavior for all employees

COR & CO Initiation of contract and at least annually thereafter. NIH

Rules of Behavior found within the NIH Annual Information

Security Training Course.

10. Disposition/Decommission

Plan.

COR & CO At least 2 weeks prior to contract expiration, or as directed by the NCATS.

11. Asset Inventory/Management Report

COR & CO A SCAP-compliant tool generated inventory of all information technology (IT) assets for hardware and software, (computers, servers, routers, databases, operating systems, etc.) that are processing HHS-owned information/data. Due within

90 days after contract award.

12. Incident Response Report (as incidents or breaches occur)

COR & CO As soon as possible and without reasonable delay and no later than 1 hour of discovery. Incident Reporting outlined within Incident

Response Plan.

13. Computer software, including the source code.

COR & CO Prior to performing any work on behalf of HHS

14. Roster Changes

•Onboarding

•Offboarding

List of Personnel with defined roles and responsibilities

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

15. Background

Investigation – Onboarding documentation when beginning contract.

COR and CO Prior to performing any work on behalf of NIH/NCATS

16. Training Records- Copy of

NIH training records for all mandatory training

COR and CO In conjunction with contract award and annually thereafter or upon request

*Unless otherwise noted, monthly progress reports and annual final reports shall be submitted electronically to the COR and/or CO.

a. Contract Closeout: In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for and provide the following items: i. Indirect cost rate proposals for all years (in which a proposal was not previously submitted); ii. Final property inventory (excluding intellectual property) and Standard Forms 1428 and

1429 (if applicable); iii. Settling all subcontract costs and any issues thereunder; iv. Subcontracting compliance reports for all years to the electronic subcontract reporting system at http://www.esrs.gov (if applicable); v. Final patent and royalty reports; vi. A contractor's release of claims, i.e., Contractor's closing statement; Contractor's Assignment of

Refunds, Rebates, and Credits; and vii. A final invoice or completion voucher.

b. Items specified in this contract and each Task Order and as described in the REPORTING REQUIREMENTS

Article in SECTION C of this contract and each Task Order 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 in each Task Order. The items shall be addressed and delivered to:

Addressee Deliverable Item No.

Contracting Officer's Representative (COR) 1-3, 6-16

Contracting Officer (CO) 1-16

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) Alternate I (April 1984) is not applicable to this contract.

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

SECTION G - CONTRACT ADMINISTRATION DATA

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

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

[To be specified prior of award]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The 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.

[To be specified prior of award]

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

ARTICLE G.3. METHOD OF ORDERING

a. Orders issued under this contract may be placed as follows if placed on a fixed-price basis, and no order terms are negotiated before issaunce:

[×] in writing [ ] via telephone [ ] via facsimile (fax) [ ] via electronic mail (e-mail) [ ] Oral

[×] Other Specify: ____________

b. The Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract.

ARTICLE G.4. TASK ORDER PROCEDURE

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

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed

Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

Contracting Officer.

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order (base and any option periods);

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

c. Evaluation and Award of Task Order Proposals

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

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each TORFP will specify how the award decision will be made.

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

ARTICLE G.5. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type

Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart

32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial

Management (OFM) via email at invoicing@nih.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 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:

Approving Official: Contracting Officer

Name- ___________ Email Address-___________

Contracting Officer Representative

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is: NIDA_INV_NCATS.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the

Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer.

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. Note: The Contractor shall not include TIN if it is a Social Security Number.

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: NCATS Scientific and Technology Support Services (STSS)

g. The IDIQ Contract Line Item as follows:

Line Item

Line Item Description

1 IDIQ Ordering Period:

NCATS Scientific and Technology Support Services (STSS)

*Resultant task orders that are CR shall specify line items with fiscal year obligations.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

mailto:invoicing@nih.gov mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

c. For cost reimbursement Task Orders, 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.6. INVOICE SUBMISSION

j. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial

Management (OFM) via email at invoicing@nih.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 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…

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