SOAR RFP HHS-NIH-NIDA-SOL-2021-001 with Attachments.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

HHS-NIH-NIDA-SOL-2021-001

3. Issue Date:

November 27, 2020

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Scientific, Operations, and Administrative Resources (SOAR) to the NIH

6. ISSUED BY:

Office of Acquisition National Institute on Drug Abuse National Institutes of Health 301 N Stonestreet Ave Bethesda, MD 20892

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 12:00 PM local time (eastern time) on December 30, 2020. 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 in the System for Award Management (SAM) prior to award of a contract. Offerors must access the Central Contractor Registration (CCR) through the System for Award Management (SAM) at http:// www.sam.gov

11. FOR INFORMATION CALL: Brian O'Laughlin

PHONE: (301) 827-5253

e-MAIL: olaughlinb@nida.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is 12:00 PM local time (eastern time) on December 7, 2020. ALL QUESTIONS MUST BE IN WRITING AND SUBMITTED VIA EMAIL to Brian O'Laughlin (olaughlinb@nida.nih.gov) and cc'd to Christine Frate (Christine.Frate@nih.gov)

Secondary Point of Contact:

Christine Frate Phone: (301) 443-3846 Email: Christine.Frate@nih.gov

RFP Number : HHS-NIH-NIDA-SOL-2021-001

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.2. CERTIFICATE OF CONFIDENTIALITY

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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

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10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Certification of Filing and Payment of Taxes

13. Past Performance Information

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

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

15. Certification of Visas for Non-U.S. Citizens

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

4. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS, IF NECESSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institutes of Health (NIH) requires qualified and experienced Contractor support on a full-range of activities, including new and in-progress research projects, program deployment and implementation, and other activities necessary to conduct the business and fulfill the mission of NIH's biomedical research program. The Contractors shall independently provide scientific, operations, and administrative resources (SOAR) to assist the NIH in meeting its operational objectives.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award 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 (minimum) nor more than a total of $3,600,713,546 (maximum) for successful performance of this contract. The $3,600,713,546 is the maximum combined amount for all contract holders under the SOAR Program.

b. The prices set forth in this ARTICLE will cover the contract period April 14, 2021 through April 13, 2026. Pricing for task orders issued with period(s) of performance beyond the parent contract period of performance end date will be agreed upon at the task order level. Task orders shall not exceed twelve (12) months past the parent contract ordering period end. Task orders will be based on the rates applicable for the last period of performance of the parent award.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract and the schedules set forth in Section J, Attachments on Fully Loaded Fixed Labor Rates, Unit Prices, other direct costs and labor catalog and categories.

d. The price schedules set forth in Section J, contain on-site and off-site hourly labor rates for each year of the contract for work to be performed within the continental United States. The hourly rates are ceiling price rates and contractors may, at their discretion, elect to propose lower hourly rates when responding to a request for a task order. Factors such as complexity of work, geographic locations, and security clearances authorize the Contracting Officer to negotiate Loaded Hourly Labor Rates suited to meet their specific task order requirements.

Contractors shall explain in their task order proposals any Loaded Hourly Labor Rates that exceed the rates in the parent contract or for new proposed labor categories, and the Contracting Officer will determine the reasonableness of the pricing as defined in FAR 15.4, Contract Pricing. Upon request of the Contracting Officer, the contractor will be required to provide supporting documentation for such rates, which may include a cost element breakdown of each Loaded Hourly Labor Rate (including profit) in accordance with the contractor's cost

- 5 -accounting system, as well as any other support information the Contracting Officer deems necessary. All rates must comply with U.S. Department of Labor rates and Service Contract Labor Standards.

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.

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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. Insurance Coverage Physicians, dentists, and other health care providers: In accordance with FAR 37.401, NIH shall only obtain the services of physicians, dentists, and other health care providers with the express understanding that the Government retains no control over the medical and professional judgments which are to be made as part of furnishing those services, the Contractor shall indemnify the Government for any liability-producing act or omission by the Contractor's physicians, dentists, and other health care providers, and the Contractor shall maintain medical liability insurance which is not less than the prevailing amount of coverage for practitioners within the local community for the medical specialty covered, and any relevant subcontract shall contain FAR Clause 52.237-7. Further, the Contractor company, any subcontractor or consultant firm, and any individual health care provider furnished under the contemplated contract, may be required to sign a HIPAA non-disclosure or business associate agreement. Consideration for that agreement is tied to the contract contemplated by this Statement of Work.

In addition, the Contractor shall also procure and maintain the following minimum insurance during the period of performance of this contract in accordance with FAR 52.228-5, FAR 52.228-7, and FAR 52.228-8 as follows:

a. $20,000 per person; and

b. $500,000 per occurence death or bodily injury.

Property damage general liability insurance is required.

Automobile Insurance (comprehensive form of policy) is required as follows:

a. $20,000 per person;

b. $500,000 per occurence for death or bodily injury; and

c. $200,000 per accident for property damage.

Workmen's Compensation and employer's Liability Insurance. A minimum amount of $100,000 is required under the contract.

Prior to applicable task order commencement, the Contractor shall furnish to the Contracting Officer (CO) a certificate or written statement certifying compliance with the above required insurance coverage. The policies evidencing required insurance shall contain an endorsement to the effect that any cancellation or any material change adversely affecting the interests of the Government shall not be effective for such a period as the laws of the state in which this contract is to be performed prescribe, or until thirty (30) days after the insurer or the Contractor gives written notice to the CO, whichever period is longer.

The Contractor agrees to insert the substance of this clause, including this paragraph, in Subcontracts under this contract that require work on a Government installation.

4. 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.

5. 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 No. TBD. (Contract Number to be determined at award)

6 . Primary Place of Performance Per the Statement of Work, the primary place of performance is the Rockville-Bethesda, Maryland area with requirements at other locations throughout the United States and Canada.

The NIH main campus is located at:

9000 Rockville Pike Bethesda, Maryland 20892

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

8. 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.

9. Contractor Backfilling of Positions on Awarded Task Orders

The Contractor must provide the Government with a suitable replacement as soon as reasonably possible but no later than four (4) weeks from the permanent departure date of the Contractor, unless otherwise approved by the Contracting Officer. 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 task order.

ARTICLE B.5. POSTING REQUIREMENTS FOR RATES

The Contractor(s) shall post their rates at their individual websites within thirty (30) days after contract award consistent with Section J Attachments (see also Article G.5 Contractor Internet Presence). The contractor consents to the government posting the URL for the contractor’s site on its website as well as utilizing the rate data in its electronic ordering and automation system.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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

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

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 under "Making Files Accessible."

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined 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*:

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

*Ad hoc reporting may be required.

2. Summary of Salient Results

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

b. Other Reports/Deliverables

1. Source Code and Object Code

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

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&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) shall 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 shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

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

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

B. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

● System Security Plan (SSP) - due within 30 days after contract award. The SSP shall 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 shall 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 shall 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 shall update the SSP at least annually thereafter.

● Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall 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.

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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.

● Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall 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 shall 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).

● POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. 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, shall 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 POA&M weaknesses to be remediated before an ATO is issued.

Thereafter, the POA&M shall be updated at least quarterly.

C. 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, shall 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 shall update and test the Contingency Plan at least annually.

● E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall 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 shall 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.

D. 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:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[X] 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).

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1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall 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 shall 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 shall 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://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

b. If the Contractor is filling a new position, the Contractor shall 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.

c. 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.

d. The Contractor shall 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.

e. All contractor and subcontractor employees shall 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.

f. 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 shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. 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).

h. The Contractor shall 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).

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

j. Within seven (7) calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the individual Contractor shall coordinate with the parent Contractor to return all identification badges to the Contracting Officer or designee.

E. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall 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

- 12 -contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-for-enterprise-architecture.html

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, 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.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall 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.

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

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall 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 shall 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.

6. The Contractor (and/or any subcontractor) shall 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 an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. 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 shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

G. Vulnerability Scanning Reports The Contractor shall 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 shall be submitted under a separate cover on monthly basis.

H. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall 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:

a. 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.

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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.

b. 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 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.

c. 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.

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

I. Security Content Automation Protocol (SCAP)-compliant diagnostic reports and DHS Continuous Diagnostics and Mitigation Program (CDM)

The Contractor and/or any subcontractor (at any tier) performing the task order may be required to maintain an effective system to monitor for, identify, and report data breaches and computer security incidents. As part of this, FedRAMP requires that the contractor or relevant subcontractor is capable of furnishing Security Content Automation Protocol (SCAP)-compliant diagnostic reports. The contractor, and/or any subcontractor at any tier, shall use SCAP-compliant and DHS Continuous Diagnostics and Mitigation Program (CDM)-compliant automated tools for active/passive scans in order to provide an inventory of all IT assets for both hardware and software. As part of this, scans to provide visibility into the security configuration compliance status of all IT assets which are processing Government information and data shall be conducted and made available. Scans to detect any security vulnerabilities in all IT assets which are processing Government information and data shall also be conducted and made available. SCAP and CDM compliant diagnostic reports shall be provided to the HHS Computer Security Incident Response Center at least once per month and provided on the first business day of each month. Each monthly report shall come from the prime contractor, or directly from the relevant subcontractor, and include roll-up reports from all of the relevant subcontractors (at any tier). The purpose of the report is to facilitate the Government being able to continuously monitor the security of any contractor or subcontractor system storing or trafficking Government data.

2. Section 508 Annual Report

The contractor shall 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: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

3. Internet Presence Report

The contractor shall submit an Internet Presence Report certifying that the contract holder is in full compliance with Article G.5 Contractor Internet Presence requirements. The report shall be submitted

- 14 -to the Contracting Officer and Contracting Officer Representative providing compliance status on all requirements under Article G.5 for the previous quarter.

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

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SECTION E - INSPECTION AND ACCEPTANCE

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

2. For the purpose of this SECTION, the Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

3. Inspection and acceptance will be performed at:

6101 Executive Blvd., Rockville, Maryland 20852

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

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

FAR Clause 52.246-4, 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).

Alternate I (April 1984) is not applicable to this contract.

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE- ORDERING PERIOD

This contract shall have an anticipated ordering period from April 14, 2021 through April 13, 2026.

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:

Item Number Description Delivered to Due Date

1. Monthly Progress Reports COR Submitted with monthly invoice and no later than 15 business days after the start of the month

2. Quarterly Meeting with COR

*This meeting shall include a Quarterly Progress Report with projections on programatic ceiling (See Article B.2)

N/A Arranged quarterly and coordinated with the COR's schedule

3. Annual Progress Report COR & CO Submitted no later than 15 business days following each Annual Contract Period

4. 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

5. Summary of Salient Results COR & CO On or before completion date of contract

6. Individual Subcontracting Report (ISR)

Submitted electronically at www.esrs.gov with Contracting Officer listed as contact

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

7. Summary Subcontract Report

(SSR)

Submitted electronically at www.esrs.gov with Contracting Officer listed as contact

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

8. 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

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Item Number Description Delivered to Due Date (Roster of employees requiring suitability investigations)

9. NIST SP 800-26

Self-Assessment Questionnaire

COR & CO Within 30 days of contract award

10. System Security Plan (SPP) COR & CO Within 30 days of contract award and updated annually

11. Security Assessment Plan/ Report (SAP/SAR)

COR & CO Within 30 days of contract award and updated annually

12. FIPPS 199 Assessment COR & CO Within 30 days of contract award

13. Independent Assessment COR & CO Within 90 days of contract award

14. POA&M COR & CO Within 30 days of contract award and updated at least quarterly

15. Contingency Plan and Contingency Plan Test

COR & CO Within 60 days of contract award and updated at least annually

16. Storage Facility

Requirements

COR & CO Within 60 days of contract award and updated annually

17. Report of new and departing employees/Employee Separation Checklist

COR & CO Within 3 working days of staff changes

18. Contractor-Employee Non- Disclosure Agreements

COR & CO Prior to performing any work on behalf of NIH/NIMH

19. Vulnerability Scanning Reports

COR & CO 10 days following each reporting period (Submitted monthly)

20. Section 508 Annual Report COR & CO 21 days following each reporting period

21. SCAP and CDM compliant diagnostic reports (applicable to certain IT Task Orders only)

COR, CO & HHS Computer Security Incident Response Center

The first business day of each month

22. Invention Reporting Requirement (see Article C.3)

CO On or before the anniversary date of the contract

23. 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/NIMH, and monthly thereafter. Offboarding-documentation, equipment and badge when leaving contract within 3 business days

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Item Number Description Delivered to Due Date

24 Background Investigation – Onboarding documentation when beginning contract.

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

25 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

26 Rules of Behavior- Signed ROB for all employees

COR and CO Initiation of contract and at least annually thereafter

27 Incident Report (as incidents or breaches occur)

COR & CO NIH/NIMH policy states as soon as possible or no later than 1 hour of discovery

28 Incident and Breach Response Plan

COR & CO Upon request from government

29 Certification of Sanitization of Government and Government Activity- Related Files, Information, and Devices.

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

30 Contract Initiation and Expiration- If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

COR & CO At contract expiration.

31 Security Assessment and Authorization (SA&A) Package

•SSP

•SAR

•POA&M

•Authorization Letter •CP and CPT Report •E-Auth (if applicable) •PTA/PIA (if applicable) •Interconnection/Data UseAgreements (if applicable) •Authorization Letter •ConfigurationManagement Plan (if applicable) •Configuration Baseline

COR & CO NIH/NIMH requires the contractor to complete the SA&A package within 90 days of initial contract award. This includes the delivery of the following items within 30 days of contract award.

•SSP

•PIA

32 FedRAMP (applicable if the product/service meets the NIST definition of a CSP)

– FedRamp Authorization

COR & CO NIH/NIMH requires FedRAMP Authorization due prior to using product.

33 POA&M updates; Revised security documentation/

COR & CO Monthly/as requested by

NIMH ISSO

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Item Number Description Delivered to Due Date Agreements,…