N02CO57019-02_CPTAC_BCR_SOLICITATION.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218

2. Request for Proposal (RFP) Number:

N02CO57019-02

3. Issue Date:

07/02/2015

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Proteomics Tumor Analysis Consortium (CPTAC) Biospecimen Core Resource

6. ISSUED BY:

National Cancer Institute Office of Acquisitions Treatment and Support Branch Riverside Five, Suite 400 8490 Progress Drive, Room 4036 Frederick, MD 21701-4998

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 2:00PM Eastern Prevailing time on 08/03/2015. 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 Central Contractor Registry (CCR) 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: Mandie S. White

PHONE: 301-624-8756

e-MAIL: whitems@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Mandie S. White Contracting Officer National Cancer Institute Office of Acquisitions, TSB http://www.sam.gov

RFP Number : N02CO57019-02

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. AVAILABILITY OF THE "FEDERAL ADP AND TELECOMMUNICATIONS STANDARDS INDEX."

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

- 3 -

11. Selection of Offerors

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. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Human Fetal Tissue

Human Embryonic Germ Cell (HEGC) Research

Human Embryonic Stem Cell (HESC) Research

5. Obtaining and Disseminating Biomedical Research Resources

6. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

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

4. Salary Rate Limitation

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

- 4 -

8. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

9. PAST PERFORMANCE FACTOR

- 5 -

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 project is to utilize a pipeline to collect, process, qualify, genomically characterize and distribute biospecimens for the Clinical Proteomics Tumor Analysis Consortium (CPTAC) and to collect, analyze, review, store and distribute data associated with this project. The project shall establish a Biospecimen Core Resource (BCR) site capable of receiving, qualifying, processing and distributing annotated biospecimens (tissue) and data from multiple Tissue Source Site (TSS) networks. The purpose of this project is to utilize a pipeline to collect, process, qualify, genomically characterize and distribute biospecimens for the Clinical Proteomics Tumor Analysis Consortium (CPTAC) and to collect, analyze, review, store and distribute data associated with this project. The project shall establish a Biospecimen Core Resource (BCR) site capable of receiving, qualifying, processing and distributing annotated biospecimens (tissue) and data from multiple Tissue Source Site (TSS) networks.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. 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 $ .

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 - 12 months

Option Period 1 - 12 months

Option Period 2 - 12 months

- 6 -

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 3 - 12 months

Option Period 4 - 12 months

Total

[Base Period and Options]

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. In addition, the following will be included in any contract resulting from this RFP:

1. Compatibility

All work performed at one Biospecimen Core Resource (BCR) must be compatible with the Operations and Technical Support (OTS) BCR by exporting data in the same format to the OTS Comprehensive Data Resource (CDR). Also, the data collected by the BCR and OTS BCR must be compatible with the format of the CPTAC Data Coordinating Center (DCC) tools and those developed during the course of the project by Proteogenomic Data Analysis Centers

(PGDAC).

2. Software

As outlined in the Statement of Work, all software developed under this contract shall be released under an open-source license.

3. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

4. CPTAC Intellectual Property Policy

In accordance with FAR 52.227-11 and 52.227-14 without Alternate IV, incorporated herein by reference, the Government retains rights to all data produced under this contract including, but not limited to, SOPs, reports, data standards and software.

Specifically, the following is the CPTAC Intellectual Property Policy and shall be adhered to for this acquisition:

- 7 -

The goal of the CPTAC Intellectual Property policy is to maximize the benefit of all research funded as part of the CPTAC program for the improvement of public health through discoveries of the scientific community. CPTAC Data Sharing and Data Release policies provide for a broad "freedom-to-operate" for all users of CPTAC data by rapidly placing all data in the public domain. Freedom-to-operate means users of the data are not restrained by lack of access to the data. They can analyze the data prior to the data being formally published in a peer-reviewed journal, which could take over 1 year in CPTAC. The CPTAC Intellectual Property policy is intended to ensure that these data are unencumbered by intellectual property claims. In addition to data, computer algorithms produced specifically to analyze CPTAC data, software source code or other resources made possible under the auspices of CPTAC will be made available to the public domain without intellectual property restrictions.

Any data produced in the CPTAC research network (whether supported by a grant or contract mechanism) shall make all information available, without requirement for licensing, for applications such as, but not necessarily limited to, the use of markers in developing assays or targets for therapeutics and diagnostics. All CPTAC research network members and affiliated institutions must acknowledge agreement to the CPTAC Intellectual Property Policy and affirm that they will not make no intellectual property claim derived from primary data produced as a member of the network.

CPTAC encourages broad use of all data coupled with a responsible approach to management of intellectual property derived from downstream discoveries that are consistent both with the recommendations cited in NIH's Best Practices for the Licensing of Genomic Inventions and the NIH Research Tools Policy. The filing of patent applications in a manner that would restrict use of CPTAC data, software and other resources could substantially diminish the value and public benefit provided by this program. Investigators and their institutions approved for use of controlled-access data sets agree to abide by this policy as specified in the terms and conditions of the CPTAC Data Use Certification.

5. Production/Workload Assignments

As outlined in the Statement of Work the Contractor shall receive tissues and clinical data from the Tissue Source Sites (TSS) for processing according to direction from the NCI Contracting Officer Representative (COR). Work will be assigned to each BCR according to tumor type and balanced with program milestones and priority. Work may be assigned or reassigned as needed to accommodate and maintain the flow, quantity and quality or products through the pipeline, ensure optimal molecular analyte quality and optimization of data accrual and sharing as outlined in the Statement of Work.

6. Cost Assumptions

For the option years, it is expected that the BCR will process more tissue and spend less time on the cost reimbursement elements; therefore, there is an anticipated reduction in the cost reimbursement elements of 50% and a > 100% increase in tissue processing. In Year 5 of the project, the work should begin to scale back to processing only out-year clinical research forms. The budget shall reflect these assumptions in addition to those described in the Statement of Work.

- 8 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. [DESCRIPTION-SPECIFICATION-WORKSTATEMENT-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 6/3/15, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 1 hard copy of these reports will be required as follows:

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

2. Summary of Salient Results

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

b. Other Reports/Deliverables

Reporting requirements in this Attachment do not relieve the BCR of the responsibility for any reporting, data exposure and data transmission requirements also enumerated in the Statement of Work.

http://www.hhs.gov/web/508/index.html

- 9 -

In addition to reports required by other terms of this contract, the Contractor shall prepare and submit the following reports:

Standard Operating Protocols - (see SOW for additional information Section E.10.c) BCR shall provide copies of SOPs directly to the NCI COR and updates/changes made to SOPs shall be provided within 30 calendar days of implementation.

Software Development Artifacts All software development artifacts and source code shall be submitted, and kept up to date, on the designated CPTAC BCR informatics sites: shared source code repository.

Reports associated with Individual TSS

Electronic copies of reports on the following activities associated with individual TSSs shall be delivered to the NCI COR as applicable :

1) If a TSS requires a training visit for shipping purposes, the BCR leading that training shall submit a report summarizing the information shared during the visit to the NCI COR within 5 business days of return travel.

2) A copy of a specific TSS's MTA shall be provided to the NCI COR directly or through the document sharing system (e.g. Sharepoint) provided to the contractor.

3) A copy of the IRB documentation or the equivalent from an individual TSS's participation in this project shall be provided to the NCI COR directly or through the document sharing system (e.g. Huddle) provided to the contractor.

4) Reports of estimated TSS case and sample inventory, and reports of planned shipments from TSS inventory to BCR, shall be provided to the NCI COR. Reports shall be submitted as part of the regular Progress Report, required below.

Reports associated with Individual Centers Electronic copies of reports on the following activities associated with individual Genome Characterization Centers (GCCs) and Proteome Characterization Centers (PCCs) shall be delivered to the NCI COR as applicable. Unless specified, Centers refers to both GCCs and PCCs.

1. Reports, of summary and individual analyte aliquot level, of shipments to Centers. Reports shall specifically enumerate re-shipment of analytes.

2. Reports shall enumerate any deviations from shipment plans, and any problems having arisen, including descriptions of problems with analytes reported back from Centers to the BCR.

3. Enumeration of administrative documents in progress and executed between BCR and Centers, including, if applicable, MTA, Data Use Agreements, and provision of TSS IRB documentation.

Reports associated with the NCI-OTS (Operations and Technical Support) Comprehensive Data Resource (CDR) Electronic copies of reports on the following activities associated with individual the Data Coordinating Center and/or NCI-OTS CDR shall be delivered to the NCI COR as applicable:

1. Reports on planned data upload format changes, including listing of dates of notification and date of implementation of data format change plans.

2. Reports on upload of BCR data files to NCI-OTS CDR, including date, batch ID, and revision level.

3. Reports on any data upload failures.

Weekly Status Reports (due electronically 3pm EST the day before the weekly status conference call)

1) The BCR shall participate in a weekly (or more frequently as needed) teleconference with the NCI COR. The meeting will review the weekly written status report (dashboard) from the BCR that shall include the following information:

a. Progress on receipt of MTA and IRB documentation from new TSSs

- 10 -

b. Number of samples, tumor types, source of normal, name of TSS and other pertinent information for each case coming through the BCR during the past week.

c. Number of samples at each stage of the BCR pipeline (in the door, pathology QC, molecular analyte extraction, analyte distribution, etc.)

d. Deviations from the SOW or any SOP should also be reported in the weekly report.

e. Reports on clinical data completion and accuracy rates, segmented by each TSS and by each batch of analytes distributed to Centers.

f. Identification of all issues/problems/delays encountered and resolution/status of each issue.

g. Other elements as required by the NCI-COR

2) Each BCR shall provide a formal semi-annual report that details the information provided in the weekly reports as well as how the BCR deviated or met the expectations established by the SOW. This report shall also detail the status of the BCR's own IRB protocol/approval for their work for CPTAC.

3) Each BCR shall provide a final report, submitted within 30 days of the date of the end of the project, detailing the work provided under the terms of the contract.

Ad-Hoc Reports The BCR shall provide reports to the NCI-COR providing answers to specific queries regarding any aspect of the BCR's supply chain logistics pipeline/sample status no more than five (5) business days after a request is made.

Project Plan for Initiating Operations The Project Plan for initiating operations shall detail the Contractor's approach and timelines for becoming fully functional. The plan shall describe:

a. Timelines

b. Scale up staffing

c. Resources required

d. Dependencies

BCR Operation Management Plan The BCR Operations Management Plan shall detail the Contractor's approach to managing the BCR. The BCR Operation Plan shall describe the structure and day-to-day operations of the BCR as well as a Project Plan describing the steps needed to begin operations. The BCR Operation Plan shall consist of the following elements:

a. Work Breakdown Structure

b. Major Workflows as Cross-Functional Flowcharts

c. Resource Management Plan

d. Organizational chart covering major BCR functions including:

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

ii. Allocation of staff

e. Service level and response times and mechanisms for responding to stakeholder/participant inquiries

f. Internal Communication Plan including interactions with the NCI COR.

g. Training of BCR personnel

h. Training of TSS personnel

i. Control of Government Furnished Information/Equipment

j. Certifications and approvals

k. Safety Plan

i. Biorepository

ii. Laboratory

l. Risk Matrix and Management including:

i. Identifiable risks and severity

ii. Mitigation strategies

- 11 -

BCR Monthly Status Report including Financial Report The BCR Monthly Status Report shall provide an overview of the contractor's activities in the previous month. It shall also identify changes in risk status to the project during that month (e.g. a risk may change from "likely" to "realized"). The report shall note any deviations from the BCR Operations Management Plan. Finally, the report shall include a monthly financial report.

TSS Communication Plan The TSS Communication Plan shall identify the methods by which the BCR will communicate with the CPTAC TSSs. The plan shall include:

a. Training of TSS staff

b. Scheduling of routine communication

c. Scheduling of shipping

d. Method for resolving defects in clinical, biospecimen, and pathology data/information submitted by the TSS

e. Method for resolving biospecimen quality issues that might arise.

NCI-OTS CDR/DCC Communication Plan The NCI-OTS CDR/DCC Communication Plan shall identify the methods by which the BCR will communicate with both the CPTAC NCI-OTS CDR and the DCC. The Plan shall include:

a. Scheduling of routine communication.

b. Method for supplying the data model to be employed, IT system information, and other input needed by the NCI-OTS CDR for determining appropriate data formats and data transmission protocols.

c. Method for interacting with the CPTAC NCI-OTS CDR and DCC in developing any project plans involving both the BCR and NCI-OTS CDR or DCC for implementing changes to the systems employed at either entity.

d. Scheduling of data uploads.

e. Method for resolving data quality issues that might arise.

PCC Communication Plan The PCC Communication Plan shall identify the methods by which the BCR will communicate with the CPTAC PCC. The Plan shall include:

1. Scheduling of routine communication.

2. Method for receiving requests from the PCCs for biospecimens and shipping biospecimens.

3. Method for resolving shipping or biospecimen quality issues that might arise.

GCC Communication Plan The GCC Communication Plan shall identify the methods by which the BCR will communicate with the CPTAC GCC. The Plan shall include:

1. Scheduling of routine communication.

2. Method for supplying the data model to be employed, IT system information, and other input needed by the GCC for determining appropriate data formats and data transmission protocols.

3. Method for interacting with the CPTAC GCC in developing any project plans involving both the BCR and GCC for implementing changes to the systems employed at either entity.

4. Scheduling of data uploads.

5. Method for resolving data quality issues that might arise.

SOP Inventory and Development Plan The SOP Inventory and Development Plan should list all the SOPs reasonably expected to be required for the execution of the repetitive tasks contained in this SOW. The Plan should include:

- 12 -

1. A prioritized listing of all SOPs that may be needed.

2. Timelines for developing the SOPs including approval by the NCI CPTAC Program Office and NCI COR.

Standard Operating Procedures Standard Operating Procedures shall be developed and approved based on the final SOP Inventory and Development Plan. All SOPs shall fully describe the procedure and adhere to a similar format to be determined by the BCR. SOPs shall be versioned and updated as needed.

Annual Certifications and Approvals The following certifications shall be confirmed in writing with the frequencies noted in the relevant Sections of the SOW. The content should conform to that noted in the relevant sections of the SOW. The format is at the discretion of the Contractor.

1. Approval from Contractor's IRB

2. Certificates of Confidentiality

3. Human subjects documentation directly relating to the BCR

4. Material Transfer Agreements between the BCR and other CPTAC entities

5. Section 508 Compliance report

6. Safety Plan

7. TSS Training

8. CLIA certification

Project Close-Out Plan The Close-Out Plan shall describe the Contractor's best judgment regarding the processes for transferring all materials and data to the government or a new vendor. The initial version of the Plan shall be submitted for review and modification six months after the initiation of the project. The final version shall be delivered three months later.

Project Summary The Project Summary Report shall describe the work accomplished against each task in this Statement of Work and its success in meeting the goals and objectives of the project. All major accomplishments produced by this work shall be described. Any issues encountered, resolutions, and lessons learned shall also be given.

In addition, the following shall be provided:

1. An inventory of:

a. Residual tissues and analytes.

b. Histopathology images and slides.

c. SOPs.

2. Government Furnished Equipment

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

1. Source Code and Object Code

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

- 13 -

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. 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 the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. 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 this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor 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.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

- 14 -

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five 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 contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS

g. Contractor - Employee Non-Disclosure Agreement(s) 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 Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS

3. Section 508 Annual Report

- 15 -

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 this contract. 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."

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 National Cancer Institute Office of Acquisitions, TSB Riverside Five, Suite 400 8490 Progress Drive, Room 4036 Frederick, Maryland 21701- 4998

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

- 16 -

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.

Please see the Statement of Work (SOW) for shipping requirements for this contract.

- 17 -

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, Contracting Officer 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 Bethesda, MD

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).

- 18 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from September 11, 2015 through September 10, 2016.

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 One (1)

September 11, 2016 through September 10, 2017

Option Period Two (2) September 11, 2017 through September 10, 2018

Option Period Three (3)

September 11, 2018 through September 10, 2019

Option Period Four (4)

September 11, 2019 through September 10, 2020

ARTICLE F.2. DELIVERIES

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

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

Item Description Quantity Delivery Schedule

(1) Project Plan for Initiating

Operations 1 Initial version with proposal; final version five

(5) days after the kick off meeting.

(2) BCR Operation Management Plan

1 Initial version with proposal; final version 30 days after contract execution

(3) BCR Monthly Status Report including Financial Status Report

1 10th calendar day of each month

(4) BCR Weekly Dashboard 1 Each Monday

(5) FIPS 199 Assessment 1 Initial version with proposal; final version 30 days after contract execution. Annual verifications are due prior to expiration of the contract

(6) IT Security Certification and Accreditation (IT-

SC&A)

1 The contractor shall submit written proof to the CO that an IT-SC&A was performed within three (3) months after contract award.

Annual verifications are

- 19 -

Item Description Quantity Delivery Schedule due prior to expiration of the contract

(7) IT Security Risk Assessment

1 Initial version with proposal; final version 30 days after contract execution. Annual verifications are due prior to expiration of the contract

(8) IT Security Plan 1 Initial version with proposal; final version 30 days after contract execution. Annual verifications are due prior to expiration of the contract

(9) IT Architecture and Design 1 Initial version with proposal; final version 30 days after contract execution. Annual verifications are due prior to expiration of the contract

(10) IT Maintenance and Backup Documentation

1 Initial version with proposal; final version 30 days after contract execution. Annual verifications are due prior to expiration of the contract

(11) SOP Inventory and Development Plan

1 Initial version with proposal; final version 30 days after contract execution

(12) Standard Operating Procedures

1 Per SOP Inventory and Development Plan

(13) TSS Communication Plan 1 Initial version with proposal; final version 15 days after contract execution

(14) DCC/CDR Communication Plan

1 Initial version 30 days after contract execution;

final version 30 days after acceptance of the initial version.

(15) PCC Communication Plan 1 Initial version 30 days after contract execution;

final version 30 days after acceptance of the initial version.

(16) GCC Communication Plan 1 Initial version 30 days after contract execution;

final version 30 days after acceptance of the initial version.

(17) CLIA certificate for pathology component

1 Must show within 90 days of contract execution

- 20 -

Item Description Quantity Delivery Schedule

(18) Annual Certifications and

Approvals 1 Due annually

(19) Project Close Out Plan 1 Initial version 60 days after contract initiation;

final version 30 days after acceptance.

(20) Project Summary Report 1 Initial version 60 days before the end of the Period of Performance;

final version 1 day before the end of the Period of Performance.

(21) Roster of Employees Requiring Suitability Investigations

1 Due within 14 calendar days of the effective date of the contract. *Any revisions to the Roster as a result of staffing changes shall be submitted within fifteen

(15) calendar days of the change.

(22) Contractor Notification of New or Departing Employee Report

1 Due within 14 calendar days of the effective date of the contract. *Any revisions to the Roster as a result of staffing changes shall be submitted within fifteen

(15) calendar days of the change.

(23) Contractor-Employee Non- Disclosure Agreements

1 Due prior to performing work under the contract.

New staff shall complete prior to performing work under the contract.

(24) Annual Section 508 Report 1 Due on or before expiration of base period of the contract and each option period, if exercised.

(25) Final Invention Statement 1 Due on or before contract expiration

(26) Annual Utilization Report 1 Due on or before contract expiration

(27) Invention Disclosure Report

2 Due on or before contract expiration

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

Addressee Deliverable Item No Quantity NCI COR Items (1) through (24) One (1) electronic copy to ncibranchcinvoices@mail.nih.gov NCI Contracting Officer Items (1) through (27) One (1) electronic copy to ncibranchcinvoices@mail.nih.gov OPERA, OEH, NIH Item (27) One (1) hard copy to OPERA;

One (1) electronic copy to ncibranchcinvoices@mail.nih.gov mailto:ncibranchcinvoices@mail.nih.gov mailto:ncibranchcinvoices@mail.nih.gov mailto:ncibranchcinvoices@mail.nih.gov

- 21 -

Addressee Deliverable Item No Quantity 6705 Rockledge Drive, Suite 310, MSC 7980 Bethesda, MD 20892-7980

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: http://www.acquisition.gov/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

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

http://www.acquisition.gov/far

- 22 -

SECTION G - CONTRACT ADMINISTRATION DATA

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

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

To be specified prior to award.

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

The 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 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

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

Name Title

To be specified prior to award

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

E-mail: TBD

- 23 -

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

Central Point of Distribution: ncibranchcinvoices@mail.nih.gov

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One courtesy copy of the original invoice shall be submitted electronically as follows:

1. The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one…