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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

N02CN35003-43

3. Issue Date:

September 9, 2013

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Cancer Prevention Clinical Trials Auditing and Informatics Support

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E148, MSC 9700 Bethesda, MD 20892-9700

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 October 8, 2013 local time on 4:00 PM EST. 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: Andrea Giuliano, Contract Specialist

PHONE: 240-276-5390

e-MAIL: Andrea.Giuliano@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is September 30, 2013 at 4:00 PM EST.

Donna Perry-Lalley Contracting Officer Office of Acquisitions 240-276-5446 http://www.sam.gov

RFP Number : N02CN35003-43

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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. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Past Performance Information

12. Information and Physical Access Security

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13. 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

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

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. TECHNICAL EVALUATION CRITERIA

4. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

5. PAST PERFORMANCE FACTOR

6. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

7. SUSTAINABLE ACQUISITION PLAN

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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.

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide integrated, comprehensive clinical trial oversight capability for the National Cancer Institute (NCI), Division of Cancer Prevention (DCP) cancer prevention clinical trials program by providing services required to perform the following tasks:

• Transition Tasks: Provide services to coordinate and integrate transition tasks.

• Task Area 1: Provide an instance of Oracle® Clinical-Remote Data Capture (OC-RDC) and the services for the data management of designated cancer prevention clinical trials and the development, maintenance and integration of data transfer and reporting mechanisms for data collected from cancer prevention clinical trials.

• Task Area 2: Provide auditing and data verification services for cancer prevention clinical trials.

• Task Area 3: Provide education and training services to staff conducting cancer prevention clinical trials.

The services provided in Task Area 2 and Task Area 3 support the primary objectives of this contract.

ARTICLE B.2. PRICES/COSTS

a. This is an 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 $19,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 01/01/2014 through 12/31/2018.

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

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION/SPECIFICATIONS/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 08/01/2013, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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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. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

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

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

a. Technical Progress Reports

1. Monthly Task Order Progress Report

The Contractor shall provide technical monthly task order progress reports. These reports shall include a summary of:

1.1 Progress on all projects in the task order for the past month including;

a. a summary of the total month's costs and level of effort by task area,

b. planned and completed auditing activities

1.2 Any problems encountered in task order management, the management and reporting of data, auditing as required per approved procedures at the Consortia sites, and developing and implementing training materials and/or programs for DCP and Consortia site staff including resolution of the problems;

1.3 Projections of the level of effort for the upcoming month by task area.

Each Monthly Task Order Progress Report shall include a report of Vulnerability Scanning on all clinical data management and other systems (as specified) being used for this contract. Each reporting period shall consist of one (1) calendar month.

An electronic copy of the report shall be delivered to the Contracting Officer's Representative (COR) and Contracting Officer (CO) within 15 calendar days of the end of each reporting period. The Monthly Task Order Progress Report is not required for the period that the Final Task Order Report is due.

2. Final Task Order Report

The Contractor shall provide a Final Task Order Report that includes a complete and comprehensive description of the work performed and the results obtained during the task order period. The Contractor shall include all deliverables as required. The Contractor shall submit an electronic copy and a hard copy of the Final Task Order Report to the COR and the CO on or before the task order expiration date.

3. Transition In Plan

The Contractor shall provide a Transition-In Plan, if required, to define and describe the process required for the coordination and implementation of an orderly, secure and efficient transition of all activities, materials, data and other documents from their predecessor.

4. Transition Out Plan http://www.hhs.gov/web/508/index.html

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The Contractor shall provide a Transition-Out Plan, if required, to define and describe the process for the transfer of contractual activities and products (including contract material, files, documents, and any other holding) to a successor contractor. This Plan should include the Contractor's approach to providing continuity of service and any other assistance deemed reasonable by NCI/DCP that may be required for the smooth transition of contract responsibility. The schedule and priorities for this transition will be established by the Contractor and the COR.

The Transition-Out Plan shall be completed 60 calendar days prior to the expiration of the last task order.

5. Manual of Operating Procedures

A Manual of Operating Procedures (MOP) shall be developed and maintained to document the Contractor's guidelines and processes for the conduct of the Task Order Statement of Work. The MOP shall be updated as directed by the COR.

6. DESK Management Report

The Contractor shall provide monthly DESK Management Reports in support of DCP reporting requirements and current DHHS methodology for measuring cost and schedule performance in contracts with a major IT component. These reports shall include but not be limited to the following information:

• a current report of actual monthly activity for the staff assigned to each project,

• the current hourly billing rate,

• the percent of time allocated to each DESK and/or other designated projects and project.

7. HelpDesk Report

The Contractor shall provide a summary report of data collected regarding incoming inquiries to the Help Desk and their resolution. These data may include but not be limited to the types of queries received, the Task Area related to the query, the frequency of each query type, amount of time queries take to answer, client and applicable contact information, description of the query and its resolution. The content of the HelpDesk Report will be determined in collaboration with the COR.

8. Site Visit Report Template

The Contractor shall prepare a template to document the findings of audits conducted during a study's life cycle. The template shall include but not be limited to the documentation of audit findings of CRF and participant record reviews, regulatory and pharmacy record review, site operations assessments, data management processes, and summary of the discussions with the clinical site staff.

9. Transition Plan - New Data Management System

If a new system or new instance of Oracle® Clinical is needed, the Contractor shall provide a transition plan which describes the testing procedures and validation according to CMMI level 3 or equivalent requirements. For the testing phase, the plan shall include:

• Monitoring the quality of data and data transmissions during the first two months of transition, and providing the COR(s) with data quality metrics such as but not limited to number of data discrepancies, transmission failures, and a report of Help Desk calls regarding technical and other difficulties encountered by end-users of the system.

• Providing a plan for 100% resolution of all issues and demonstrating that resolution has been attained. The contractor shall assure successful integration of the chosen system with existing DCP and NCI systems as required, and assure compliance with the requirements for IT development, maintenance and/or support in this contract.

The COR will evaluate this plan and resolution and decide if final deployment of the new system shall proceed. As part of the transition plan, the Contractor shall propose alternate solutions should the new clinical trials database be disapproved by the COR.

New informatics systems developed by the Contractor under this contract shall be compatible with applicable NCI standards and initiatives.

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10. Ad Hoc and Routine Data Reporting

The Contractor shall provide routine and ad hoc reports and datasets from data in OC-RDC and/or DESK for DCP data management, clinical trial management and regulatory activities. Reports may include but not be limited to:

• Routine and standard reports of clinical trials data that may include participant accrual, demographics, adverse events, participant status, lab findings, biomarker information, response assessments and trial results.

• Specialized reports for preparation of FDA annual reports on DCP-sponsored IND protocols. The reports may include but are not limited to those that would be used by the regulatory contractor for developing mandatory submissions to the FDA or ad hoc reports to other entities as requested by DCP staff.

• Specialized reports for the Principal Investigator of each study may include but not be limited to specified data regarding participants, treatment, adverse events, and final study results.

• Special ad hoc reports or datasets as requested or approved by the COR(s), including detailed reports that may be used for statistical analysis

11. Clinical Trials Resource (CTR) Report

The Contractor shall provide a concise summary report of the findings of the review of the content of the DCP consortia clinical trials resource webpage(s) for Consortia 2003 and Consortia 2012 (http:// prevention.cancer.gov/clinicaltrials/management/consortia). This report shall include but not be limited to:

3.1 webpage content requiring update,

3.2 webpage structure and format requiring modification and/or update, including the functionality of links and access to relevant sites,

3.3 proposed updates to the webpage based on review findings,

3.4 proposed enhancements to improve usability.

12. Education Plans

The Contractor will develop education plans, based on the identified needs, as requested and submit all proposed educational plans to the COR for review and approval prior to implementation. Proposed educational plans shall include but not be limited to the following:

• Goals, objectives

• Program or course description

• Method, i.e., webinar, lecture, roundtable discussion, teleconference, written materials

• Contractor level of effort

• Budget

b. Other Reports/Deliverables

1. Source Code and Object Code

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

2. Information Security and Physical Access Reporting Requirements

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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.d. 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.

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(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

h. Vulnerability Scanning Reports

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The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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.

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:

9609 Medical Center Drive Bethesda, MD 20892

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

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

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

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from January 1, 2014 through December 31, 2018.

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,

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

Deliverables

Item Description Quantity Delivery Schedule 1 Roster of Employees Requiring

Suitability Investigations 1 electronic copy to the COR and the CO

Within 14 calendar days of the task order award date and within 15 calendar days of any revisions to the roster.

2 Section 508 Conformance Certification

1 electronic copy to COR and the CO

On the expiration date of each task order

3 IT Security Plan (IT-SP) 1 electronic copy to the COR Within thirty (30) calendar days of the effective date of the task order and every third year provided a new task order is awarded for three consecutive years or as needed

4 IT Risk Assessment (IT-RA) 1 electronic copy to the COR and the CO

Within thirty (30) calendar days from award of each task order.

5 FIPS 199 Assessment 1 electronic copy to the COR and the CO

Within thirty (30) calendar days from award of each task order

6 IT Security Certification and Accreditation (IT-SC&A)

1 electronic copy to the COR and the CO

Within three (3) months from award of the initial task order

7 Security Control Assessment 1 electronic copy to the COR and CO

As specified in each task order

8 Reporting of New and Departing Employees

1 electronic copy to the COR and the CO

Within five (5) business days of staffing changes or as required

9 Contractor-Employee Non- Disclosure Agreement(s)

1 electronic copy to each Contracting Officer's Representative (COR) and the Contracting Officer (CO)

Prior to commencement of work under each task order.

10 Vulnerability Scanning Report 1 electronic copy to the COR and the CO

To be included in the Monthly Task Order Progress Report

11 Manual of Operating Procedures 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

Within 6 months of the start of the first Task Order or as directed by the

COR

12 Ad Hoc Project Plans 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

Within 21 calendar days of the COR's request or as directed by the COR

13 Monthly Task Order Progress Reports

5 electronic copies (One copy to the COR, one to each of the Task Order Monitors and one to the CO)

Within 15 calendar days following each month being reported.

14 Final Task Order Report 5 electronic copies (One copy to the COR, one to each of the Task Order Monitors and one to the CO)

On or before the Task Order expiration date

15 Final Transition In Plan As defined by the COR Within 7 calendar days of task order award

16 Transition Out Plan As defined by the COR 60 calendar days prior to the expiration of the last task order

17 Technical Documentation 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

As requested by the COR

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Item Description Quantity Delivery Schedule 18 Ad Hoc Clinical Data Reports and

Data Sets As defined by the COR As directed by the COR

19 DESK Management Reports 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

Within 15 calendar days following each month being reported.

20 Routine and Ad hoc reports from data in OC-RDC and DESK

As defined by the COR As directed by the COR

21 Transition Plan for implementation of new data management system

1 electronic copy to the COR, the Task Order Monitors and the CO

As directed by the COR

22 Site Visit Report Templates 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

Within 30 calendar days of the task order award date.

23 Preliminary Site Visit Report for each site visit 1 electronic copy to each of the following:

• Task Area 2 COR

• DCP PIO

Within 48 hours, or two business days, after the Site Visit

24 Final Site Visit Report for each Site Visit

1 electronic copy to each of the following:

• Task Area 2 COR

• DCP PIO

Within 15 business days of the Site Visit

25 Initiation Visit Report 1 electronic copy to each of the following:

• Task Area 2 COR

• DCP PIO

Within 15 business days of the Site Visit

26 Clinical Trials Resource (CTR) Report

4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

On the expiration date of each Task Order or as directed by the COR

27 Educational presentations and other materials for DCP Site Coordinators' Meetings

As defined by the COR As requested by the COR

28 DCP Help Desk report 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

Within 15 calendar days following each month being reported.

29 Education Plans As defined by the COR As requested by the COR 30 Consortia Standard Operating

Procedures (SOPs) 4 electronic copies (One copy to the COR and one to each of the Task Order Monitors)

As requested by the COR

31 Inventory and disposition of all materials collected, stored, maintained and /or developed under this contract, including but not limited to, documents, data (source documents, data files, databases), programs and computer software

Inventory: 2 copies (One copy to the COR and one to the

CO)

Disposition: As defined by the

COR

Inventory within 60 days prior to the expiration date of the last task order.

Disposition by the contract expiration date or as directed by the COR

32 Source Code and Object Code As directed by the COR Task order expiration date 33 Name(s) and location(s) of the commercial records storage facility, copy of the storage facilities certificate of compliance with NARA requirements

2 copies (One copy to the COR and one to the CO)

Within 30 calendar days prior to the transfer of materials to storage.

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

Contracting Officer Representatives

(CORS)

TBN

Contracting Officer TBN Protocol Information Office Division of Cancer Prevention

TBN

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 (Cost-Reimbursement Task Orders)

Alternate I (April 1984) is not applicable to this contract (Fixed Price Task Orders) http://www.acquisition.gov/comp/far/index.html

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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 352.242-70 (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

TBD TBD

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

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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.

c. 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 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.

ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 and 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.

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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 single attachment.

2. Save the single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number (e.g., if you are submitting Invoice 123456, save the single attachment as "Ash Stevens_Invoice 123456") [Note: Please do not use special characters such as (#, $, %,*, &, !) when saving your attachment. Only the underscore symbol (_) is permitted.]

3. Transmit the saved single attachment via e-mail to the appropriate branch's Central Point of Distribution as identified in subparagraph 2.b. below. Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contract Number_ Contract Title_ Contractor's Name_ unique Invoice number

(e.g, HHSN2612XXXXXC_Clinical Genetics Support_Ash Stevens_Invoice 12345) [Note:

The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a "proper invoice." Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the original invoice mailed to NIH's Office of Financial Management.]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch B - ncibranchbinvoices@mail.nih.gov .

c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

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d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

g. The Contract Title is:

Cancer Prevention Clinical Trials Auditing and Informatics Support

h. Contract Line Items as follows:

Line Item # Line Item Description

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.5. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS

a. The Government encourages the contractor to pay small business subcontractors along an accelerated timetable to the maximum extent practicable. The Government recommends payment to small business subcontractors within 15 days of receipt of proper documentation.

b. Include the substance of this article, including this paragraph (b), in all subcontracts with small business concerns.

c. This policy does not modify the application or operation of the Prompt Payment Act.

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ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at:

http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix Q_HHS Contracting Guide.pdf.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared as determined by the Contracting Officer.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf http://www.cpars.gov

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ARTICLE H.2. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.3. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.4. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.5. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http:// oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.

ARTICLE H.6. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause…