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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number:

N02CO65002-45

3. Issue Date:

November 22, 2016

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Biospecimen Core Resource

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health

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 local time on Thursday, December 22, 2016. 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 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: Sara M. McLaurin

PHONE: 240-276-5438

e-MAIL: mclaurinsm@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Questions about the solicitation should be sent by email to mclaurinsm@mail.nih.gov. The cutoff date for receipt of questions on the solicitation is December 6, 2016. Responses to the questions will be issued as an amendment to the solicitation.

Sara M. McLaurin Contracting Officer Office of Acquisitions http://www.sam.gov

RFP Number : N02CO65002-45

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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. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

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12. ROTC Access and Federal Military Recruiting on Campus

13. Certification of Filing and Payment of Taxes

14. Past Performance Information

15. Information and Physical Access Security

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

17. 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. Cost and Pricing Data

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

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. TECHNICAL EVALUATION FACTORS

4. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

5. 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 purpose of this contract is to establish a new Biospecimen Core Resource (BCR) to support various cancer genomics studies. The BCR consists of two components: Biospecimen Processing Center (BPC) and the Center for Cancer Genomics (CCG) Biorepository and Archive (CBA).

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 $1,000 (minimum) nor more than a total of $49,900,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 06/01/2017 through 05/31/2022.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract and the following schedule. Upon delivery and acceptance of the item(s) described in each Task Order, the Government shall pay to the Contractor the [unit price(s)/costs] set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Item Unit(s) Price/Unit

d. Ordering procedures are described in The METHOD OF ORDERING Article in SECTION G of this contract.

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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.

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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 07/25/2016, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following NCI Branch Distribution Mailbox: ncibranchbinvoices@mail.nih.gov. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50MB, the Contractor shall divide the deliverable into files of 50MB each.

All deliverables shall be limited to five file attachments or less.

The subject line of email and file attachment shall read as follows: Deliverable_Contract Number_Task Order Number_Vendor Name_Deliverable Description_ Due Date

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."

a. Program Management Deliverables

1. BPC Program Management Plan

The BPC Program Management Plan shall detail the Contractor's approach to initiating and managing the BPC.

The BPC Program Management Plan shall describe the structure and day-to-day operations of the BPC and the steps needed to begin operations. The BPC Program Management Plan shall consist of the following elements:

A. Work Breakdown Structure B. Schedule including all major activities and milestones C. Major Workflows as Cross-Functional Flowcharts D. Resource Management Plan

i. Organizational chart covering specific BPC functions (pathology, molecular analyte preparation, informatics, and administration)

ii. Key Personnel

iii. Roles and Responsibilities covering specific BPC functions (clinical outreach, pathology review, molecular analyst isolation, quality program at a minimum)

iv. Allocation of staff

v. Training regimens at the BPC

vi. Control of Government Furnished Information/Equipment

E. Financial Plan - Financial Resource plan should support the fixed unit prices proposed.

i. Monthly projected expenditures for the duration of the project

ii. Specific details by the labor categories and the estimated hours for each month of the project.

iii. Identify any financial risks for this project

iv. Projected capital equipment expenses mailto:nicbranchbinvoices@nih.gov http://www.hhs.gov/web/508/index.html

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F. Communication Plan detailing interactions with:

i. NCI

ii. Genomic Data Commons (GDC), Genomic Characterization Centers (GCC), Tissue Source Sites (TSS), and Genome Data Analysis Centers (GDAC)

iii. Research community

G. Risk Matrix and Management including:

i. Identifiable risks and severity

ii. Mitigation strategies

H. Deliverable Schedule

i. Project Plan for commencing operations including:

ii. Timelines

iii. Scale up staffing Dependencies

iv. Certifications

I. IT system description including:

i. Data transition plan ii.. Data model to be used iii.. Security plan

iv. Backup and restoration/disaster recovery plan

J. Safety Plan

i. Biorepository

ii. Laboratory

K. Change management plan for informatics systems

L. Risks matrix and external dependencies and provide a mitigation plan

M. Quality Management Plan

i. Strategy for incorporation and development of SOPs to govern all task processes

ii. Quantity (both mass and number) of cases and biospecimens being received per TSS

iii. Pathologic quality of biospecimens being received per project, per cancer, and per TSS

iv. Case genotype mismatching rates per TSS

v. Quantity of nucleic acid yield per weight of tissue, per project, per cancer, and per TSS

vi. Quality of nucleic acid per processing batch per project, and per cancer

vii. Completion rates of clinical data per case, per project, per cancer, and per TSS viii.Other parameters as determined by the NCI COR.

xi. Standard Operating Procedures (SOP)

a. Established list of SOPs

b. SOPs to be developed

The Contractor shall submit a Program Management Plan which shall include the above information and shall cover each task awarded under the Task Order. The Program Management Plan shall include a Cost Control Plan providing a detailed approach to managing the costs of the BPC and describing fiscal controls for the BPC.

The Program Management Plan shall include a Quality Management Plan which provides details of the Contractor's Quality Management System (QMS). The QMS shall operate at sufficient detail and capture data over time to support the emergence of trends in key operating results. All task processes must be governed by detailed SOPs. The format for the narrative components shall be in Microsoft Word or Adobe PDF documents;

the format for schedules and related information shall be in Microsoft Project documents.

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2. CBA Program Management Plan

The CBA Program Management Plan shall detail the Contractor's approach to initiating and managing the CBA.

The CBA Program Management Plan shall describe the structure and day-to-day operations of the CBA and the steps needed to begin operations. The CBA Program Management Plan shall consist of the following elements:

A. Work Breakdown Structure

B. Schedule including all major activities and milestones

i. Major Workflows as Cross-Functional Flowcharts

ii. Resource Management Plan

iii. Organizational chart covering specific CBA functions (pathology, molecular analyte preparation, informatics, and administration)

iv. Key Personnel

v. Roles and Responsibilities covering specific CBA functions (clinical outreach, pathology review, molecular analyst isolation, quality program at a minimum)

vi. Allocation of staff

vii. Training regimens at the CBA

viii. Control of Government Furnished Information/Equipment

C. Financial Plan - Financial Resource plan should support the fixed unit prices proposed.

i. Monthly projected expenditures for the duration of the project

ii. Specific details by the labor categories and the estimated hours for each month of the project

iii. Identify any financial risks for this project

iv. Projected capital equipment expenses

D. Communication Plan detailing interactions with:

i. NCI

ii. Genomic Data Commons (GDC), Genomic Characterization Centers (GCC), Tissue Source Sites (TSS), and Genome Data Analysis Centers (GDAC)

iii. Research community

E. Risk Matrix and Management including:

i. Identifiable risks and severity

ii. Mitigation strategies

F. Deliverable Schedule

G. Project Plan for commencing operations including:

i. imelines

ii. Scale up staffing Dependencies

iii. Certifications

H. IT system description including:

i. Data transition plan

ii. Data model to be used

iii. Security plan

iv. Backup and restoration/disaster recovery plan

I. Safety Plan

i. Biorepository

ii. Laboratory

J. Change management plan for informatics systems

K. Risks matrix and external dependencies and provide a mitigation plan

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L. Quality Management Plan

i. Strategy for incorporation and development of SOPs to govern all task processes

ii. Quantity (both mass and number) of cases and biospecimens being received per TSS

iii. Pathologic quality of biospecimens being received per project, per cancer, and per TSS

iv. Case genotype mismatching rates per TSS

v. Quantity of nucleic acid yield per weight of tissue, per project, per cancer, and per TSS

vi. Quality of nucleic acid per processing batch per project, and per cancer

vii. Completion rates of clinical data per case, per project, per cancer, and per TSS viii.Other parameters as determined by the NCI COR.

ix. Standard Operating Procedures (SOP)

a. Established list of SOPs

b. SOPs to be developed

The Contractor shall submit a Program Management Plan which shall include the above information and shall cover each task awarded under the Task Order. The Program Management Plan shall include a Cost Control Plan providing a detailed approach to managing the costs of the CBA and describing fiscal controls for the CBA.

The Program Management Plan shall include a Quality Management Plan which provides details of the Contractor's Quality Management System (QMS). The QMS shall operate at sufficient detail and capture data over time to support the emergence of trends in key operating results. All task processes must be governed by detailed SOPs.

The format for the narrative components shall be in Microsoft Word or Adobe PDF documents; the format for schedules and related information shall be in Microsoft Project documents.

3. Monthly Progress Reports

The Contractor shall submit Monthly Progress Reports which include the following information:

A. Operations Status which shall provide a comprehensive view of the status of the CBA including

i. Current status of cases received at the CBA.

ii. Data uploads to the GDC.

iii. New/revised SOPs submitted for approval.

iv. Outwardly facing communications including but not limited to presentations by staff and training of TSSs.

v. Identified issues and risks along with remediation strategies.

B. Cost Control

i. Hours worked by resource ii Current period expenditures and expenditures for Task Order year to date iii Estimated Price At Completion iv Changes to the projected monthly burn rate for the duration of the effort

C. Issue Tracking List for nonconforming events

D. Quality Management Status

i. Biospecimen and molecular analyte tracking

ii. Performance audits, molecular quality of samples

E. SOPs - both a list of all SOPs that have been modified in the previous month and copies of the SOPs

The first report shall be due on the 10th of the month following the first full month of performance. Thereafter, reports shall be due on or before the 10th calendar day following each reporting period. The reports shall be submitted in Adobe PDF or Microsoft Word.

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4. Transition-In/ Start Up Plan The Contractor shall submit a "Start-up/Transition-In Plan" which shall describe the process for transferring all materials and data from the Government or another Contractor at the beginning of the Task Order period of performance. The Transition Plan shall include a draft plan for comprehensive data import from the information systems. Based on the approved plan, the Contractor shall deliver a comprehensive data import from the information systems within 30 days of the each Task Order award.

5. Final Progress Report The Contractor shall submit a Final Progress Report which shall describe the following:

A. The work accomplished against each task in the Statement of Work

B. Success in meeting the goals and objectives of the project

C. All major accomplishments

D. Any issues encountered, resolutions, and lessons learned

E. An inventory of

i. residual tissues and analytes

ii. histopathology slides

iii. SOPs

iv. Government Furnished Equipment

F. A complete download of the content of the LIMS system, Biorepository, and any other informatics systems used

The narrative components shall be in Adobe PDF or Microsoft Word format. The inventories shall be in Microsoft Excel format or as defined by the NCI COR. Download of the informatics system, biorepository, and any other informatics systems used shall be in an electronic format to be determined.

6. Final Transition Plan

The Contractor shall submit a "Final Transition Plan" which shall describe the process for transferring all materials and data to the Government or another Contractor at the conclusion of the Task Order period of performance. The Final Transition Plan shall include a draft plan for comprehensive data export from the information systems. Based on the approved plan, the Contractor shall deliver a comprehensive data export from the information systems at least one (1) month before the end of the Task Order period of performance.

7. Summary of Salient Results

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

8. Updates of Certifications and Training

The Contractor shall submit annual written confirmation of the following certifications and/or training requirements:

A. Institutional Review Board (IRB) Approval letter B. Documentation verifying

i. Human subjects training

ii. Safety training

iii. Security Training

The Contractor shall update each certification and maintain the updated document in the CCG Program Office SOP

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b. Task Order Management Deliverables

9. Report of USDA Designated Biobased Products In accordance with FAR clause 52.223-2, Affirmative Procurement of Biobased Products under Service and Construction Task Orders, the Contractor shall report to http://www.sam.gov, with a copy to the Contracting Officer any USDA-designated biobased products purchased during the period of October 1-September 30 of each Task Order year. This report shall be submitted no later than October 31 of each year during Task Order performance and on the expiration date of each Task Order.

10. Service Contract Reporting In accordance with FAR clause 52.204-15, Service Contract Reporting Requirements for Indefinite Delivery Contracts (Jan 2014), the Contractor shall enter and submit the following Service Contract Report data elements into http:// www.sam.gov, with a copy to the Contracting Officer annually, by October 31st for services performed under this contract during the preceding Government fiscal year (October 1 - September 30). SCR data elements:

A. Contract Number B. The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

C. Total number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

D. Data reported by first-tier subcontractors that have provided services under this contract, as applicable.

i. First-tier Subcontract number (including subcontractor name and DUNS number)

ii. The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous Government fiscal year.

11. Section 508 Annual Report The Contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of the Task Order. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ Task Ordering/technology/vendors.html under "Vendor Information and Documents."

12. Disaster Recovery Plan The Contractor shall develop and submit a draft Disaster Recovery Plan for review and approval by the COR Due 30 calendar days after Task Order award.

13., 14., and 15. Invention Disclosure Report, Annual Utilization Report and Final Invention Statement 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 COR. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the COR on the expiration date of the Task Order.

c. I nformation System Deliverables

16. Information Systems Security Plan The Contractor shall provide an Information Systems Security Plan in accordance with HHSAR Clause 352.239-72, Security Requirements for Federal Information Technology Resources. The IT-SP shall be consistent with and shall provide a detailed approach to IT Security plan submitted as part of the Contactor's proposal (prior to Task Order

- 12 -award). The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under the Task Order. If the IT-SP only applies to a portion of the Task Order, the Contractor shall specify those parts of the Task Order to which the IT-SP applies.

The Contractor shall submit the IT-SP Due 30 calendar days after Task Order award. The Task Order shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis, and submit the updated IT-SP annually on the anniversary date of Task Order award.

17. Roster of Employees Requiring Suitability Investigations The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under each Task Order who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted Due 14 calendar days after Task Order award.

18. IT Risk Assessment (IT-RA) The Contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy. The Contractor shall update the IT-RA on an annual basis.

19. FIPS 199 Assessment The Contractor shall submit a FIPS 199 Assessment, which shall be consistent with the cited NIST standard, due 30

20. IT Security Certification and Accreditation (IT-SC&A) The Contractor shall submit written proof that an IT-SC&A was performed within three (3) months after Task Order award. For all Task Orders with a period of performance of more than 12 months, the Contractor shall perform an annual security control assessment and provide verification to the COR that the IT-SC&A remains valid.

21. Report of New and Departing Employees The Contractor shall notify the Contracting Officer's Representative (COR) and the Contracting Officer (CO) due five

(5) working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "employee Separation Checklist", attached in Section J, ATTACHMENTS, of this Task Order, when a Contractor/SubContractor employee terminates work under this Task Order. All documentation shall be provided to the COR and/or CO upon request.

22. Contractor-Employee Non-Disclosure Agreements The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each Contractor and subcontractor employee who may have access to non-public Departmental information under this Task Order. This form is located at: Https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/Nondisclosure.pdf.

23. Vulnerability Scanning Reports The Contractor shall report the results of the required monthly special vulnerability scans due 10 calendar days following the end of each reporting period. This report may be included as part of the Monthly Progress Report. If not included in the Monthly Progress Report, the Contractor shall submit it under separate cover.

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24. System Review Analysis and Performance Metric Standards The Contractor shall assess the standing system for baseline performance capability and propose metric indicators for reporting that demonstrate operational maintenance success. The Contractor shall submit the analysis due 30

25. Management of Sensitive Information Plan The Contractor shall develop and submit a draft plan for management of sensitive information due 30 calendar days after Task Order award.

26. Report on Status of Minimum Background Investigation Clearances (HSPD-12 Security Requirements)

The Contractor shall perform and report on the status of background investigations in accordance with Homeland Security Presidential Directive 12. The Contractor shall provide monthly updates on background investigations as part of the Monthly IT Status Report Requirement.

27. Monthly IT Status Report Requirement

The Contractor shall submit IT Status Reports in accordance with HHS Office of the Chief Information Officer (OCIO) Enterprise Performance Life Cycle (EPLC) Policy Adherence. See http://www.hhs.gov/ocio/ policy/2008-0004.001.html.

28. Configuration Management Plan

The Contractor shall provide documentation of the existing system configuration and any alterations to it. The documentation shall include a plan for revisions and upgrades to its baseline functionality and structure as an artifact document if any software is to be developed for the Task Order period. The Contractor shall submit the plan due 30 days after Task Order award.

29. Data Collection Plan

The Contractor shall develop and submit a Data Collection Plan in accordance with HHSAR 352.224-70 Privacy Act due 30 days after Task Order award.

30. 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.

31. Final Data Set, cleaned and Locked

The Contractor shall develop and submit a Data Collection Plan due 30 days after Task Order award as part of the Program Management Plan. Data sets distributed under this policy shall remove data with personal identifiers and other variables that might enable individual participants to be identified, such as outliers, dates, and study sites. The Final Data Set, cleaned and locked shall be delivered to the NCI COR, or designee, upon Task Order expiration.

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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 annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. 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 National Institutes of Health Office of Acquisition Bethesda, Maryland 20892

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

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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, task order 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, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Office of Acquisitions Prevention, Control, and Population Sciences Branch 9609 Medical Center Drive

1E634 MSC 9705

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 06/01/2017 through 05/31/2022.

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 (Attachment 3) and Article C.2, Reporting Requirements 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 delivery schedule included in each Task Order issued.

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required ro be delivered in electronic format to the designated NCI Branch Distribution Mailbox:

ncibranchbinvoices@mail.nih.gov 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. The subject line of the email shall read as follows: Deliverable_Contract Number_Task Order Number_Vendor's Name_Deliverable Description_Due Date.

Deliverable Number

Deliverable Name DUE DATE

Project Management Deliverables 1 BPC Program Management Plan Due 30 days after task order award 2 CBA Program Management Plan Due 30 days after task order award 3 Monthly Progress Report Due 10 calendar days after end of each reporting period 4 Transition In/Start Up Plan Due 30 days after task order award 5 Final Progress Report On or before Task Order expiration 6 Final Transition Plan DRAFT: Due 180 calendar days prior to the task order expiration

FINAL: Due 90 calendar days prior to the task order expiration 7 Summary of Salient Results Due on Task Order expiration date 8 Updates of Certifications and Training Annually on the anniversary of the Task Order award

Task Order Management Deliverables 9 Report of USDA Designated Biobased

Products Due October 31 of each year of Task Order performance and on the expiration date

10 Service Contract Act Reporting Due October 31 of each year of Task Order performance 11 Section 508 Annual Report Annually on the anniversary of Task Order award 12 Disaster Recovery Plan Due 30 calendar days after Task Order award 13 Invention Disclosure Report Due the date of Task Order completion 14 Annual Utilization report Annually on the anniversary of Task Order award 15 Final Invention Statement Due the date of Task Order completion

Information Systems Deliverables 16 Information Systems Security Plan Due 30 calendar days after Task Order award and update annually as required per Task Order 17 Roster of Employees Requiring

Suitability Investigations Due 14 calendar days after Task Order award

18 IT Risk Assessment (IT-RA) Due 30 calendar days after Task Order award and update annually as required per Task Order

19 FIPS 199 Assessment Due 30 calendar days after Task Order award 20 IT Security Certification and

Accreditation (IT-SC&A) Due 90 calendar days after Task Order award and updated annually as required per Task Order mailto:ncibranchbinvoices@nih.gov

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Deliverable Number

Deliverable Name DUE DATE

21 Report of New and Departing Employees

Due 5 working days after staff changes that require suitability investigations

22 Contractor-Employee Non-Disclosure Agreements

Prior to having access to any non-public information

23 Vulnerability Scanning Reports Due monthly, 10 calendar days following the end of each task order reporting period

24 System Review Analysis and Performance Metric Standards

Due 30 calendar days after Task Order award

25 Management of Sensitive Information Plan

Due 30 calendar days after Task Order award

26 Report on Status of Minimum Background Investigation Clearances (HSPD-12 Security Requirements)

To be provided with Monthly IT Status Reports

27 Monthly IT Status Report Due monthly, 10 calendar days following the end of each task order reporting period

28 Configuration Management Plan Due 30 calendar days after Task Order award.

29 Data Collection Plan Due 30 calendar days after Task Order award.

30 Source Code and Object Code Due on the Task Order expiration date 31 Final Data Set, cleaned and locked Due on the Task Order expiration date 32 Annual Report of Government Owned

Contractor Held Property Due annually within 30 calendar days of the anniversary date of contract award

b. The above items shall be addressed and emailed to: ncibranchbinvoices@mail.nih.gov

c. The following addresses are provided for general correspondence and other deliverables:

Addressee Deliverable Item No. Quantity

Contracting Officer's Representative

(COR)

Center for Cancer Genomics National Cancer Institute email address TBD

1-8, 11, 12, 16-31 Electronically to the email address above

Contracting Officer (CO) Office of Acquisitions (OA) National Cancer Institute

1-7, 9-22 Electronically to the email address above

Division of Extramural Inventions and Technology Resources (DEITR)

OPERA, OER, NIH

6705 Rockledge Drive, Suite 310, MSC 7980 email address TBD Bethesda, MD 29892-7980

13, 14, 15 Electronically to www.iedison.gov and to ncibranchbinvoices@nih.gov

Government Property Officer

TBD

32 Email - TBD mailto:ncibranchbinbox@nih.gov http://www.iedison.gov mailto:ncibranchbinvoices@nih.gov

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

52.242-17, Government Delay of Work (April 1984).

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

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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:

TBD

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

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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 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

- 22 -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;

• 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 16.505(b)(1)(ii);

ii. For orders exceeding the simplified acquisition threshold up to $5.5 Million, in accordance with 16.505(b)(1)(iii); and,

iii. For orders exceeding $5.5 Million, in accordance with FAR 16.505(b)(1)(iv).

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ARTICLE G.4. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

E-mail:

The Contractor shall submit an electronic copy of the payment request to the approving official…