RFP_75N91019R00002.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

75N91019R00002

3. Issue Date:

January 17, 2019

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Logistical and IT support for the NCI Central Institutional Review Board (CIRB)

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive, Room 1E610 Bethesda, MD 20892 MSC 9705

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 12:00 PM local time on February 19, 2019. Offers will be valid for 180 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

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

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: Jame Chang

PHONE: 240-276-5424

e-MAIL: jame.chang@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The deadline for receipt of questions concerning this RFP is 2:00 PM Eastern Time on January 24, 2019. Secondary Point of Contact:

Rukshani Levy Team Leader, Contracting Officer, NCI OA rukshani.levy@nih.gov http://www.sam.gov

RFP Number : 75N91019R00002

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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

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. 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. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Certification of Filing and Payment of Taxes

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11. Past Performance Information

12. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT

PROCUREMENTS

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

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Section 508

5. Additional Technical Proposal Instructions

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. Additional Business Proposal Instructions

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

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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 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 Logistical and IT support for the NCI Central Institutional Review Board (CIRB) is a project of the National Cancer Institute (NCI) to develop, implement, and manage a centralized model of Institutional Review Board (IRB) review for multi-site, NCI-sponsored clinical trials. The goal of the Initiative is two-fold: to streamline regulatory compliance and decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide by providing a single, centralized review that can be utilized by local IRBs participating in NCI-sponsored multi-center trials; and to maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level.

ARTICLE B.2. ESTIMATED COST - OPTION

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

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

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

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

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period

Option A for Increased Quantity

Option B for Increased Quantity

Option Period 1

Option A1 for Increased Quantity

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option B1 for Increased Quantity

Option Period 2

Option A2 for Increased Quantity

Option B2 for Increased Quantity

Option Period 3

Option A3 for Increased Quantity

Option B3 for Increased Quantity

Option Period 4

Option A4 for Increased Quantity

Option B4 for Increased Quantity

Total

Base Period and Option(s)

ARTICLE B.3. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $TBD.

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

CLIN, Task, Number, or Description

Start Date of Period or Increment of Performance

End Date of

Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost

Plus Fee ($) (as appropriate)

TBD TBD TBD TBD TBD TBD

Total

[Base Period and Option(s)]

*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $TBD .

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

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ARTICLE B.4. 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.5. 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.

1. Annual Escalation Factor for Direct Labor - In no event shall the annual labor escalation factor exceed 2.4%. All Offerors' are to to assume a 2.4% annual escalation for direct labor in the preparation of proposals. For any staff proposed that are currently employed by the Contractor, the Government shall only accept salaries proposed in the base year that are reflective of the individual's current annual salary plus no greater than a 2.4% escalation.

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

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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, dated January 17, 2019, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number is 09-25-0217 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 attachment to the following NCI Branch Distribution mailbox: ncibrancheinvoices@mail.nih.gov or to the designated COR.

Any electronically-submitted documents shall be conformant 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 HHS Section 508: 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, we refer the contract holder 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/create-accessible-documents

This contract holder shall use the relevant or respective checklist as a Section 508 report for each document it submits per file type (e.g., Microsoft Word, Microsoft Excel, PDF, etc.) at the end of the year, in lieu of the Section 508 Annual Report for Vendors.

The subject line of the email shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

a. Technical Progress Reports

1. Monthly Progress Report

This report shall include a description of the activities and accomplishments performed during the reporting period consisting of the first full calendar month of performance plus any fractional part of the previous month. Thereafter, the reporting period shall consist of each calendar month. All reports shall be provided electronically to the CO and the COR. Reports shall be due on or before the 15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the annual or final report is due.

Specifically, the following shall be included in the report:

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/making-files-accessible/checklist/pdf/index.html https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.itic.org/policy/accessibility/vpat https://www.itic.org/policy/accessibility/vpat https://www.section508.gov/best-practices https://www.section508.gov/content/build/create-accessible-documents https://www.section508.gov/content/build/create-accessible-documents https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc https://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

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1. Executive Summary

2. Overview of SOW Activity by Task

3. Help Desk Activity Summary

i. The Help Desk Activity Summary shall enumerate the number of inquiries received via email and phone and voicemail for the month; category of inquiry; average response time; and number of inquiries per category for the reporting month.

4. Enrollment Activity Summary

i. The Enrollment Activity Report shall track enrollment activities including the following: total number of institutions enrolled; number of enrollment applications pending and where they are in the process; number of new applications received per month; number of new applications approved per month; number of Authorization Agreements signed per month; master listing of enrolled signatory institutions; listing of signatory institution's components and affiliates;

listing of Cancer Centers enrolled; listing of NCORP enrolled; and additional data points, when requested.

5. Adult and Pediatric CIRB C-PIRAT "Compliance with Timeframes" Report for following metrics:

i. 7 working days between Approval-on-Hold and CIRB Application Received

ii. 14 (Adult CIRBs & CPC CIRB) or 21 (PedCIRB) working days from Approval-on-Hold and CIRB meeting date

iii. 2 working days between date of CIRB outcome letter sent and CIRB review of outcome letter

iv. If teleconference is necessary, must be scheduled within 7 working days after CIRB review

v. 14 calendar days between CIRB response sent and Study Chair response received

vi. The actual days required for each process step mentioned above and a summary that states the % that met the CPIRAT criteria

6. "Compliance with Timeframes" Report for following metrics

i. 3 working days after CIRB meetings for distribution of approval letters

ii. 7 working days after CIRB meetings for distribution of outcome letters that are not approvals

iii. Minutes ready for vote at next meeting

iv. CIRB approval of new studies within 28 calendar days (when CIRB meets twice a month) or within 42 calendar days (when CIRB meets once a month)

v. CIRB approval of Study-Specific Worksheet within 3 working days

7. Quality Assurance Audit Reports

i. The Quality Assurance Audit (QA) Report shall outline the risks and opportunities to accurate, efficient and effective CIRB operations. The report shall include an assessment of each of the major CIRB operational functional areas. Each functional area shall have a risk/opportunity assessment and a strategy to address each risk/opportunity identified. This shall include both the actual audit results and the list of the audits performed.

8. Status Report of IT Change Orders

9. Key Definitions Appendix

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2. Annual Progress Report

This report shall include a summation of the results of the entire contract work for the annual period covered. The annual report shall include a comprehensive list of studies and status. This comprehensive report is designed to identify work load and will include the number of new studies, number of continuing reviews, and the number of amendments. Reports shall be due on or before the 15th calendar day following the end of each reporting period. An annual report will not be required for the period when the Final Report is due.

3. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved.

b. Other Reports/Deliverables

1. Final Transition-In Plan ( Not applicable to incumbent )

The Contractor shall submit a Final Transition-In Plan to the Contracting Officer's Representative (COR) for approval within 7 days of contract award. The Final Transition Plan shall describe the steps to ensure that:

a. Staff are oriented, trained, and available to assume all tasks described in this SOW.

b. The processes are in place to ensure compliance with IRB and other Federal regulations on protocols under the authority of the NCI CIRB.

c. Board meetings will continue their established schedules.

d. Worksheets and other submissions from enrolled institutions are reviewed according to established timelines.

e. The helpdesk is functional with staff responding to inquiries within the established timelines.

2. Board Members' Attendance, Completion of Assignments, and Continuing Education

This spreadsheet/log tracks each CIRB member's activity including attendance at meetings;

participation in continuing education webinars, and completion of primary reviewer assignments.

Submission of this spreadsheet/log is due annually separate from the Annual Progress Report.

3. Tracking Log of Accreditation Tasks

This log identifies requirements to maintain AAHRPP accreditation and tracks progress on completion of each requirement upon the request of the COR.

4. Help Desk Tracking Log of Interactions with Local Sites

This log/spreadsheet tracks communications through the CIRB Help Desk. Log/spreadsheet must contain inquiry contact information, communication receipt time and method received, synopsis of inquiry, priority level given, time response sent, total time between receipt of question and distribution of answer, Operations Office responder and solution. The Help Desk Tracking Log is due upon request from the COR.

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5. Evaluation Report of Local Operations

Evaluate members of the local context subcommittee as well as topics for review and discussion.

Provide details for member qualifications and member participation as well as an evaluation of the internal local context process. This report shall be due 6 months from contract award and every six months following.

6. Unanticipated Problems and Compliance Report

The Contractor shall provide a monthly report that lists the details of all of the Unanticipated Problems and Serious or Continuing Noncompliance as reported by the enrolled institutions or investigators.

Any items determined to be reportable to the FDA or OHRPP shall be fully described.

7. Standard Operating Procedures

The Contractor shall ensure that all CIRB SOP's are in compliance with federal laws and regulations, and that all administrative activities and CIRB actions are in compliance with the CIRB SOP's. These updated SOP's shall be updated and due annually.

8. Continuing Education Plan

The Contractor shall submit a final draft of the Continuing Education Plan for COR approval within three (3) months of contract award. The plan shall include goals, objectives, planned topics, delivery approaches, time frame and method of evaluation. The continuing education is fro board members.

9. Quality Control Plan

The Contractor shall submit a final draft of the Quality Control Plan for COR approval within three (3) months of contract award. The Quality Control Plan shall cover the quality standards, metrics, and measurement processes that ensure the quality, timeliness, and integrity of all services provided in the contract.

10. Project Management Plan

The Contractor shall submit a draft of the Project Management Plan within 3 months of contract award. The plan shall describe how the Contractor shall meet project requirements and ensure that project requirements are tracked and fulfilled. This shall include how the Contractor will provide the COR with up-to-date financial, project status and staffing information. The draft shall also include a visual representation of the plan and a method for evaluating and adjusting the plan.

The plan itself, visual representation and evaluation mechanisms must be completed within 3 months of contract award. All three will be reviewed and modified on a quarterly basis.

11. Transition-Out Plan

The Contractor shall develop and submit a draft Transition-Out plan 6 months prior to the expiration date of the contract. The plan shall describe the Contractor's strategy for transferring work from this contract to a successor contractor. The plan shall include a system for transfer of policies and procedures; transfer of relevant files, records, materials, and data; all source code and object code developed, modified, and/or enhanced under the contract; transition of all activities, and transition of all Cancer Trials Support Unit (CTSU)-Enterprise applications, as appropriate.

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Upon receipt of COR feedback, the Contractor shall submit the Final Transition Plan to the Government no later than 4 months prior to the expiration date of the contract. The Contractor shall also deliver all source code and object code on or before the contract expiration date.

12. 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.

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.

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• 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 POAM 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 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).

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

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

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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 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.

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 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/ocio/ea/documents/proplans.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 https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://www.hhs.gov/ocio/ea/documents/proplans.html

- 14 -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 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.

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.

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.

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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.

13. 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."

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

http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

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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

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

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

c. Inspection and acceptance will be performed at:

National Institutes of Health National Cancer Institute Division of Cancer Treatment & Diagnosis (DCTD) Cancer Therapy Evaluation Program (CTEP) 9609 Medical Center Drive Bethesda, MD 20892 MSC 9705

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from September 1, 2019 through August 31, 2020.

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

Option Option Period Option Period 1 September 1, 2020 - August 31, 2021 Option Period 2 September 1, 2021 - August 31, 2022 Option Period 3 September 1, 2022 - August 31, 2023 Option Period 4 September 1, 2023 - August 31, 2024

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item Description Quantity Delivery Schedule A.1. Monthly Progress Report 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Reports shall be due on or before the 15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the annual or final report is due.

A.2. Annual Progress Report 1 copy to ncibrancheinvoices@mail.nih.gov

Reports shall be due on or before the 15th calendar day following the end of each reporting period. An annual report shall not be submitted when the final report is due.

A.3. Final Report 1 copy to ncibrancheinvoices@mail.nih.gov

The report shall be due on or before the expiration date of the contract.

B.1. Final Transition-In Plan 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 7 days of contract award

B.2. Board Members' Attendance, Completion of Assignments, and Continuing Education

1 copy to the COR Reports shall be due on or before the 15th calendar day following

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Item Description Quantity Delivery Schedule the end of each reporting period.

B.3. Tracking Log of Accreditation Tasks

1 copy to the COR Upon request by the COR

B.4. Help Desk Tracking Log of Interactions with Local Sites

1 copy to the COR Upon request by the COR

B.5. Evaluation Report of Local Operations

1 copy to the COR This report shall be due 6 months from contract award and every six months following

B.6. Unanticipated Problems and Compliance Report

1 copy to the COR Due monthly on or before the 15th calendar day following the end of each reporting period.

B.7. Standard Operating Procedures

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Due on or before the anniversary date of the contract following the end of each reporting period.

B.8. Continuing Education Plan

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 3 months of contract award

B.9. Quality Control Plan 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 3 months of contract award

B.10. Project Management Plan 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 3 months of contract award and quarterly thereafter

B.11. Transition-Out Plan 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Draft due 6 months prior to the expiration date of the contract and the final due no later than 4 months prior to the expiration date of the contract.

B.12. Source & Object Code 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Upon the expiration date of the contract, B.13. Security Assessment and Authorization (SA&A)

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 3 months after contract award. The Contractor shall update this on an annual basis.

B.14. System Security Plan(SSP)

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 30 days after contract award. The Contractor shall update this on an annual basis.

B.15. Security Assessment Plan/Report (SAP/SAR)

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 30 days after contract award. The Contractor shall update this on an annual basis.

B.16. Independent Assessment 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 90 days after contract award.

B.17. POA&M 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 30 days after contract award. The Contractor shall update this on an annual basis.

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Item Description Quantity Delivery Schedule B.18. Contingency Plan and

Contingency Plan Test 1 electronic copy to ncibrancheinvoices@mail.nih.gov

Within 60 days after contract award.

update The Contractor shall update this on an annual basis.

B.19. Roster of Employees Requiring Suitability Investigations

1 electronic copy to ncibrancheinvoices@mail.nih.gov

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.

B.20. Contractor - Employee Non-Disclosure Agreement(s)

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Prior to performing any work under this acquisition.

B.21. Vulnerability Scanning Reports

1 electronic copy to ncibrancheinvoices@mail.nih.gov

No later than 10 days following the end of each reporting period.

B.22. Section 508 Annual Report

1 electronic copy to ncibrancheinvoices@mail.nih.gov

Reports shall be due on or before the 15th calendar day following the end of each reporting period.

B.23. Multiple Project Director Leadership Plan

1 electronic copy to ncibrancheinvoices@mail.nih.gov

In the event of a change in any of the Project Directors named in the Key Personnel Article in SECTION G of this contract.

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

Addressee Deliverable Item No Contracting Officer's Representative

(COR) or designated NCI PI [To be named]

TBD

A.1. to A.3.