75N91021R00021 RFP with Attachments.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92.218 as amended.

2. Request for Proposal (RFP) Number:

75N91021R00021

3. Issue Date:

September 29, 2021

4. Set Aside:

[ ] No

[X] Yes:Task Areas 3 & 5 are reserved for Small Business Concerns- See Part IV Section L

5. Title : Cancer Trials Support Unit (CTSU)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E606, MSC 9705 Rockville, MD 20850

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 PM Eastern Time on November 15, 2021. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Chris Shih

PHONE: 2402767451

e-MAIL: chris.shih@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Any requests for additional information, questions and/or clarifications concerning this RFP must be submitted in writing to the contract specialist at: chris.shih@nih.gov on or before 2:00 PM EST on October 15, 2021 with the subject line: Questions- RFP 75N91021R00021

Pooja Rathore Contracting Officer Office of Acquisitions pooja.rathore@nih.gov https://www.sam.gov/SAM/

RFP Number : 75N91021R00021

- 2 -

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. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

f. COMMITMENT OF PUBLIC FUNDS

g. PROMOTING EFFICIENT SPENDING

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. CONCEPT REVIEW

k. PREPARATION COSTS

l. SERVICE OF PROTEST

m. LATE PROPOSALS AND REVISIONS

n. USE OF NON-GOVERNMENT REVIEWERS

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

- 3 -

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

13. Past Performance Information

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

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

- 4 -

PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to provide broad-based, centralized and fully integrated operational, administrative, regulatory, information technology (IT), and logistical support services to support the participation of multiple sites both nationally and internationally in multi-institutional cancer trials led by NCI-supported clinical trial organizations.

The contractor(s) shall furnish all the necessary services, qualified personnel, material, equipment, and facilities,not otherwise provided by the Government as needed to perform the work as defined in the Statement of Work.

The contractor(s) shall coordinate and integrate all activities including staffing decisions, prioritizing support for projects,and managing and monitoring any subcontracts and consultants for task orders which will includes one or more of the task areas below and as defined in the Statement of Work. Offerors must propose services under Task Area 1 and under any one or more from Task areas 2 through 6. The contract includes the following Task Areas:

Task Area 1: Project Kick-Off Meeting/Transition Activities Task Area 2: CTSU Core Support Services and the CTSU Enterprise of Systems Task Area 3: Awareness, Education, and Training (AET) Task Area 4: Site Study Set-up Task Area 5: Protocol and Scientific Writing Support (PSWS) Task Area 6: Electronic Patient-Reported Outcomes (PROs)

Note: Task Area 1 will be awarded to all vendors selected to be in the multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) pool for each task area. It is anticipated that NCI will award a base contract to a single contractor for Task Area 2 and multiple contractors for Task Areas 3, 4, 5, and 6.

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 $2,000 (minimum) nor more than a total of $548,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period August 1, 2022 through July 31, 2032.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract.

- 5 -

d. 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.

Indirect Rate Ceiling - The Government reserves the right to negotiate a ceiling rate for all Indirect Rates proposed.

- 6 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated September 29, 2021, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. Privacy Act System of Records Number 09-25-0200 is applicable 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 via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibrancheinvoices@mail.nih.gov.

Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five file attachments or less.

The subject line of the email and file attachment name shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

Task Order Reports and Deliverables: The frequency and specific content of these reports and deliverables will be determined within each individual Task Order. Reports and deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued.

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."

Checklists to ensure appropriate formatting can be found at HHS Section 508 Accessibility Checklists. Document or document-type specific testing shall serve in lieu of the Section 508 Annual Report for Vendors, which is located at:

https://www.itic.org/policy/accessibility/vpat .

In addition, the Contractor shall refer to the following two GSA Section 508 pages for guidance on developing electronic documents for accessibility and Section 508-conformance:

• GSA Section508.gov. Best Practices. https://www.section508.gov/best-practices

• GSA Section508.gov. Create Accessible Electronic Documents https://www.section508.gov/content/build/ createaccessible-documents

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to Task Order award. All technical mailto:ncibrancheinvoices@mail.nih.gov https://www.section508.gov/best-practices https://www.section508.gov/content/build/createaccessible-documents https://www.section508.gov/content/build/createaccessible-documents

- 7 -progress reports shall preferentially utilize common Project Management performance and value measures such as:

● Return on Investment

● Productivity

● Cost of Quality (Cost of Quality/Actual Cost)

● Cost Performance (Earned Value/Actual Cost)

● Schedule Performance (Earned Value/Planned Value)

In all cases the reports are intended to provide sufficient detail to understand the contractor's approach and progress to addressing the technical requirements. The intent is to provide a brief snapshot of the contractor's plans and progress. Brevity and a dash-board approach to all reports are strongly encouraged.

The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and project manager and/or their designee(s) regarding project plans and progress.

[Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

Please Note: The deliverables under each Task Order will be assigned at Task Order award. It is anticipated that the following deliverables and reports may be required under Task Orders for this contract:

1. [X] Monthly Task Order Progress Reports (with a requirement for Monthly Expense Reports)

[ ] Quarterly

[ ] Semi-Annually

2. [X] Annual Task Order Progress Reports

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

[ ] Final Task Order Report - Upon final completion of the contract

3. [X] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

4. Ad Hoc Reports

The Contractor shall provide an Ad Hoc Report per the Contractor Officer Representative request.

The reports shall include but not limited to financial tracking, management, trend analysis, and system schedule updates.

5. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 500 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

6. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and

- 8 -the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

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

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements. (Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

7. Task Order Project Plan

A Task Order Project Plan shall be provided, for each task area outlined in the Statement of Work.

The initial Project Plan shall be provided within 15 days of the Task Order award.

8. Kick-off Presentation

The Contractor shall provide a presentation and participate in discussion of best practices and other standardized procedures that will be used under all Task Orders for the Base Statement of Work, as well as a discussion of potential expansion or improvement of the CTSU program.

9. Kick-off Meeting Summary Report

Submit a Meeting Summary Report that includes the Contractor’s recommendations for best practices, potential expansion and improvement of the CTSU Program.

10. 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.

11. Standard Operating Procedures

The Contractor shall have in place a set of Standard Operating Procedures (SOPs) to describe the process for completing the tasks required by the SOW. The COR will be provided the opportunity to review and comment on the SOPs before the procedures are implemented. If not already established, the SOPs shall be developed and provided to the COR for review. The SOPs shall be reviewed annually and changes to the SOPs shall be provided to the COR for review.

12. Annual VPAT

The Contractor shall submit an annual VPAT in accordance with the schedule set forth by

The Contracting Officer (CO)/Contracting Officer's Representative (COR). The VPAT and Instructions for completing the report are available at: https://www.itic.org/policy/accessibility/vpat. The applicable VPAT is the VPAT 2.4 (February 2020) or current version.

c. INFORMATION AND/OR PHYSICAL SECURITY DELIVERABLES

The Contractor shall submit the following reports as required by Section H.12 of this contract. Additional information can be found can be found https://wiki.nci.nih.gov/display/NSCI/Package+Artifact+Checklist

13. Valid Authority to Operate 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 https://wiki.nci.nih.gov/display/NSCI/Package+Artifact+Checklist

- 9 -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.

SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide a final complete SA&A package within 120 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package

14. NCI FISMA Starter Kit Due within 30 days after contract award. The NCI FISMA Starter Kit documents comprise the SA&A documents that need to be complete first to define the parameters for the remaining SA&A effort. These documents include the FIPS-199 Categorization (FIPS-199), E-Authentication Risk Assessment (E-Auth), Privacy Impact Assessment (PIA), and the NCI Business Impact Analysis (BIA). All Starter Kit documents must use the NCI templates found at https://wiki.nci.nih.gov/display/NSCI/FISMA+Security+Templates+and+Forms

15. Configuration Management Plan Due within 60 days after contract award. The configuration Management Plan will document how systems will be configured to provide secure configurations within the framework defined by NIST SP 800-128 Guide for Security-Focused Configuration Ma of Information Systems.

https://csrc.nist.gov/publications/detail/sp/800-128/final. The contractor will submit using the NCI configuration management plan (CMP) template found at https://wiki.nci.nih.gov/display/NSCI/ FISMA+Security+Templates+and+Forms

16. System Security Plan (SSP) Due within 60 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.

17. Security Assessment Plan/Report (SAP/SAR) SAP due 60 days after the contract award. SAR due 120 days after 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. 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.

18. Independent Assessment https://wiki.nci.nih.gov/display/NSCI/FISMA+Security+Templates+and+Forms https://csrc.nist.gov/publications/detail/sp/800-128/final https://wiki.nci.nih.gov/display/NSCI/FISMA+Security+Templates+and+Forms https://wiki.nci.nih.gov/display/NSCI/FISMA+Security+Templates+and+Forms

- 10 -

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 S 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).

19. POA&M

Due 120 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Miles 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 POAM weaknesses to be remediated before an ATO is issued.

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

20. Contingency Plan and Contingency Plan Test Due 120 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 O, 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.

21. Roster of Employees Requiring Suitability Investigations

● 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.

● 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.

● 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.

● 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.

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

- 11 -

● 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.

● 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.

● 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).

● 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).

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

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

22. Notification of Departing Employees 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.

23. Contractor Employee Separation Checklist 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 when 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.

24. 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.

25. 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.

26. Training Records The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

- 12 -

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before TBD. Thereafter, reports shall be due on or before the 15th Calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer Office of Acquisitions National Cancer Institute National Institutes of Health 9609, Medical Center Drive Bethesda, Maryland 20892- 9705

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

- 13 -

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.

- 14 -

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, Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute 9609 Medical Center Drive Rockville, MD 20850

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 52.246-7, Inspection of Research and Development - Fixed Price (August 1996).

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

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

- 15 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from August 1, 2022 through July 31, 2032.

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION,WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Description Delivery Schedule Technical Reports 1a. Monthly Task Progress Order Reports 1st working day of each reporting period

1b. Monthly Task Order Expense Reports 1st working day of each reporting period

2. Annual Task Order Progress Reports

Within fifteen (15) calendar days following each reporting period

3a. Final Task Order Report

On or before task order expiration date

3b. Draft Task Order Report

Due 45 calendar days prior to the Task Order completion date

4. Ad Hoc Reports As requested by the COR

5. Summary of Salient Results On or before the expiration date of the contract

Other Reports/ Deliverables

6. Financial Conflict of Interest

(FCOI) Report Within fifteen (15) calendar days following each reporting period

7. Task Order Project Plan Within fifteen (15) days of Task Order Award

8. Kick-off Presentation of best practices and procedures to accomplish the task(s)

Within sixty (60) calendar days following contract award

9. Kick-off Meeting Summary Report

Within fifteen (15) calendar days following contract award

10. Source Code and Object Code

Unless specified, due upon the expiration date of the contract

11. Standard Operating Procedures (SOPs)- Annual review and changes

Sixty (60) calendar days after the effective date of the contract award and provide a statement within thirty (30) days after each year that the SOPs have been reviewed thereafter.

For SOP Changes, fifteen (15) calendar days after the effective date of the change

12. Annual VPAT Within thirty (30) calendar days following each reporting period

- 16 -

Description Delivery Schedule Information and Physical Security Deliverables

13. Valid Authority to Operate Within one hundred twenty (120) calendar days after contract award

14. FISMA Starter Kit Documents including FIPS-199, E-Auth, PIA, BIA

Within thirty (30) calendar days after contract award

15. Configuration Management Plan

Within sixty (60) calendar days after contract award

16. Systems Security Plan (SSP) Within sixty (60) calendar days after contract award

17. Security Assessment Plan/

Report (SAP/SAR) SAP Within sixty (60) days after contract award. SAR within one hundred twenty (120) days after contract award. The Contractor, in coordination with the NIH shall conduct/ assist in the assessment of the security controls and update the SAR at least annually, thereafter

18. Independent Assessment Within ninety (90) calendar days after contract award

19. POA&M Within one hundred twenty (120) calendar days after contract award

20. Contingency Plan and

Contingency Plan Test Within one hundred twenty (120) calendar days after contract award

21. Roster of Employees Requiring Suitability Investigations

Within fourteen (14) calendar days after contract award.

Revisions to Roster due within seven (7) calendar days of any change

22. Notification of Departing Employee

The Contractor and any subcontractor shall notify the CO and COR and system ISSO within fifteen (15) days

23. Contractor Employee Separation Checklist

Within two (2) days of the employee's exit from the contract

24. Contractor NDA Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

25. Vulnerability Scanning Reports

No later than ten (10) days following the end of each month

26. Training Records To the CO and/or COR within thirty (30) days after contract award and annually thereafter or upon request

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

Addressee Deliver To Deliverable Item No

Contracting Officer’s Representative (COR) ncibrancheinvoices@mail.nih.gov 1-26

Contracting Officer (CO) ncibrancheinvoices@mail.nih.gov 1-10, 12-26 mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

- 17 -

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide TBD at the Task Order level direct labor hours. The labor hours include vacation, holiday, and sick leave. These labor hours exclude/include (TBD at the Task Order level) subcontractor labor hours.

b. The Contractor shall have satisfied the requirement herein if not less than 80% nor more than 120% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer Hours than the minimum specified number of direct labor Hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of Hours by which the number of direct labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

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

- 18 -

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 to award

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

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD at time of award TBD at time of award

ARTICLE G.3. 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

- 19 -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 in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

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.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

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

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated.

Generally, the Contractor will be asked to demonstrate the following as appropriate:

● Understanding of the requirements;

● Experience and capability on similar tasks;

- 20 -

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

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

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

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

● References to evaluate past performance; and

● Cost/Price to perform the task order.

d. 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 whose proposal is most advantageous to the government

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,500 unless the following exception(s) apply:

i. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

i. For orders exceeding $3,500 up to the simplified acquisition threshold, in accordance with FAR…