CPICSOLICITATION.pdf

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AGENCY-WIDE CAPITAL PLANNING AND INVESTMENT CONTROL (CPIC) SUPPORT

CPIC SOLICITATION

SECTION 1: CONTRACT TYPE

1.1 MINIMUM AND MAXIMUM CONTRACT VALUE

1.2 OVERVIEW OF PRICING SCHEDULES

SECTION 2: DELIVERIES OR PERFORMANCE

2.1 ORDERING PERIOD

2.2 PERIOD OF PERFORMANCE FOR TASK ORDERS

2.3 NOTICE TO THE GOVERNMENT OF DELAYS

2.4 DELIVERABLES

2.5 PERSONEL

2.6 PLACE OF PERFORMANCE

SECTION 3: IDIQ STATEMENT OF WORK

3.1 BACKGROUND

3.2 PURPOSE

3.3 PROJECT SCOPE

3.4 CONSTRAINTS

3.5 DEFINITIONS

3.6 CONTRACT LEVEL PROGRAM MANAGMENT

3.7 DESCRIPTION OF WORK:

TASK 1 – CONTRACT LEVEL TASK ORDER MANAGEMENT

TASK 2 - CAPITAL PLANNING AND INVESTMENT CONTROL (CPIC) OVERSIGHT SUPPORT

TASK 3 – CAPITAL PLANNING AND INVESTMENT CONTROL (CPIC) INDIVIDUAL INVESTMENT SUPPORT

SECTION 4: CONTRACT ADMINISTRATION DATA

4.1 FDA INVOICE REQUIREMENTS

4.2 CONTRACTING OFFICER

4.3 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

4.4 TECHNICAL DIRECTION

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4.5 CONTRACTOR’S PRIMARY POINT OF CONTACT (POCs)

4.6 TRAVEL COSTS

4.7 OTHER DIRECT COSTS (ODC)

4.8 GOVERNMENT FURNISHED PROPERTY (GFP)

4.9 CORRESPONDENCE PROCEDURES

SECTION 5: REQUESTING, PLACING, AND PROCESSING ORDERS

5.1 GENERAL TASK ORDER PROCESSING

5.2 AUTHORIZED ORDERING OFFICIALS

5.3 ORDERING PROCESSES AND PROCEDURES

5.4 TASK ORDER PROCESSING

SECTION 6: SPECIAL CONTRACT REQUIREMENTS

6.1 DISCLOSURE OF INFORMATION

6.2 CONTRACTOR PERFORMANCE EVALUATIONS

6.3 METHODS OF OPERATION

6.4 ORGANIZATIONAL CONFLICTS OF INTEREST

6.5 CONDITIONS OF PERFORMANCE

6.6 FDA 1335 PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006)

6.7 FDA 1350 ACCESS TO NON-PUBLIC INFORMATION

6.8 CONTRACTOR CLOSEOUT RESPONSIBILITIES

6.10 DRESS

6.11 INSURANCE REQUIREMENTS

6.12 NOTICE OF AVAILABILITY OF FUNDS / CONTINUING RESOLUTION

6.13 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

6.15 PERSONNEL QUALIFICATIONS

SECTION 7: SOLICITATION PROVISIONS

FAR PROVISIONS INCORPORATED BY REFERENCE

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FULL TEXT FAR SOLICITATION PROVISIONS

SECTION 8: CONTRACT CLAUSES

8.1 FAR CLAUSES INCORPORATED BY REFERENCE

8.2 FULL TEXT FAR CLAUSES

8.3 HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS (HHSAR) Clauses

8.4 FULL TEXT HHSAR CLAUSES

SECTION 9: LIST OF RFP ATTACHMENTS

ATTACHMENT 1: TASK ORDER SOW

ATTACHMENT 2: INSTRUCTIONS TO OFFERORS AND EVALUATION CRITERIA

ATTACHMENT 3: IDIQ LABOR CATEGORY DESCRIPTIONS

ATTACHMENT 4: IDIQ PRICING SHEET

ATTACHMENT 5: TASK ORDER PRICING SHEET

ATTACHMENT 6: PAST PERFORMANCE QUESTIONAIRRE

ATTACHMENT 7: FDA 3398 PROTECT NON PUBLIC INFORMATION

ATTACHMENT 8: PERSONNEL SECURITY CHART

ATTACHMENT 9: SUBCONTRACTOR CONSENT FORM

ATTACHMENT 10: COMMERCIAL CLIENT AUTHORIZATION FORM

SECTION 10: GFI APPENDICES

APPENDIX A: Standard Federal Budget CPIC Timeline

APPENDIX B: Investment List

APPENDIX C: CPIC Standard Operating Procedures (SOP)

APPENDIX D: Scorecard

APPENDIX E: Sample Monthly Status Report (MSR)

APPENDIX F: EPLC Artifact Description

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SECTION 1: CONTRACT TYPE

This is a single award, Indefinite Delivery Indefinite Quantity (IDIQ)-type task order contract.

At the discretion of the Contracting Officer, the Government may use a variety of contract types under this contract for each task order including: Firm Fixed Price (FFP), Labor Hour (LH), or a combination thereof.

Each Request For Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of task order type.

Specific requirements tailored to meet a particular center program needs will be included in each RFTOP, including specific deliverables and schedules for the deliverables. Each RFTOP shall include the specific Center requirements, performance standards, and a quality assurance plan. The period of performance of each task order will be established upon the issuance of the order. Deliverables are to be determined upon the issuance of each task order.

1.1 MINIMUM AND MAXIMUM CONTRACT VALUE

(a) Award of the base period of the initial task order is the guaranteed minimum for the IDIQ contract.

(b) Estimated maximum ceiling for this contract is $17.3 million.

1.2 OVERVIEW OF PRICING SCHEDULES

The unit prices specified in labor hour task order shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the task order. However, in no event shall the Contractor perform, or be paid for any work which exceeds the not-to exceed dollar amount of a task order.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable unit price for a task order shall be the unit price for the time period in which the services are estimated to be performed, as agreed to by the Government and the Contractor at the time the task order is issued. The price(s) specified in FFP task orders issued under this contract is/are fixed and not subject to adjustment.

Each Labor Hour task order shall contain a ceiling price. The Contractor shall comply with FAR 52.232-7 in regards to the ceiling price for the individual task order(s).

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SECTION 2: DELIVERIES OR PERFORMANCE

2.1 ORDERING PERIOD

The ordering period is five years from the effective date of award.

2.2 PERIOD OF PERFORMANCE FOR TASK ORDERS

Period of Performance for task orders will be as specified in individual task orders. Two constraints apply to the period of performance for task orders. First, individual task orders may not exceed 5 years (inclusive of option periods). Second, individual task orders may not extend 6 months beyond the IDIQ Ordering Period.

2.3 NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer, and COTR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

2.4 DELIVERABLES

Deliverables shall be specified in the task orders released under this contract. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

2.5 PERSONEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to task orders awarded.

2.6 PLACE OF PERFORMANCE

The contractor may be required to work on site at the government or off site as required in individual task order. Specific location information will be specified in each task order. Most FDA Centers and Offices operate predominantly in the Washington, DC Metropolitan area with concentrations in the FDA's Maryland locations of Bethesda, College Park, Laurel, Rockville, and White Oak.

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SECTION 3: IDIQ STATEMENT OF WORK

INTRODUCTION

3.1 BACKGROUND

The Clinger-Cohen Act (CCA) of 1996 requires agencies to use a disciplined Capital Planning and Investment Control (CPIC) process to acquire, use, maintain and dispose of information technology (IT).

It also encourages the use of performance- and results-based management of these initiatives. The Federal Acquisition Streamlining Act requires that IT initiatives be tied to mission and strategic goals;

have cost, schedule and performance goals; and achieve on average 90 percent of these goals. The Federal approach to CPIC for IT has been the select-control-evaluate model that has been championed by the Office of Management (OMB), Government Accountability Office (GAO), and industry experts since the early 1990s.The Food and Drug Administration Agency (FDA) is responsible for adhering to the Office of Management and Budget’s (OMB) and General Accountability Office’s (GAO) mandated policies to monitor costs of IT Systems and to ensure IT investments (See GFI APPENDIX B for a List of current IT Investments) are meeting agency initiatives as identified in strategic plans. The FDA follows a formal Capital Planning and Investment Control (CPIC) Process to comply with OMB and GAO mandates and requires contractor support to assist in this effort.

3.2 PURPOSE

The purpose of this IDIQ contract is to obtain contractor capital planning and investment control support services throughout FDA. The Contractor will support the Capital Planning process at the governance and investment levels. These services include portfolio and investment, maintenance and support;

project tool support; and legislative and executive branch guidance and support. Support includes:

review with comment from verified sources, research of supporting materials from internal and external sources, documentation for portfolio or investment submissions, use of related tools, collection of trends and analysis on best practices geared toward leading the Agency on a trajectory of improvements in investment scores. Individual task orders will be issued to obtain specific services at the portfolio or investment level.

3.3 PROJECT SCOPE

The contractor shall provide assistance in executing capital planning and investment control at the FDA.

The expected level of CPIC support provided by the contractor is broad and shall cover all FDA Centers and CPIC Phases from Concept to Disposition. The support provided at the FDA level will be in support of portfolio and investment oversight activities and at the Center level support will be investment specific.

For Agency level support, the contractor shall:

A. Review investment documents and budget submissions to ensure compliance with:

a. Strategic planning initiatives

b. Agency and Department policy

c. OMB and GAO guidance

B. Provide guidance on legislative compliance

C. Research and share best practices (with source materials) on how to manage investments, congruent with the most current mandates and reporting requirements

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D. Communicate with all FDA CPIC stakeholders such as FDA’s Enterprise Architecture (EA) and Center Architects, FDA’s Governance committees, CPIC Staff, and Investment managers

E. Assess portfolio health in terms of budget, cost, schedule and performance, using best practices or models presented to and approved by CPIC staff

F. Provide guidance for investment owners and other identified stakeholders on corrective action plans

G. Work with investment managers as needed to translate requirements and constraints for their multiple stakeholders (e.g., ITIRB (usually with minimal technical knowledge), business managers (usually with no CPIC knowledge), to accomplish mutual Agency goals of favorable scores and continued Agency IT funding

H. Provide assistance in improving FDA’s CPIC internal control processes, as part of execution of a continuous improvement plan, through research and documented recommendations for CPIC approval

I. Assist FDA Center Investment Managers and their support staff or contractors, in submitting high quality reports and submissions to executive managers, OMB, or other key stakeholders

J. Assist CPIC staff in translating incoming reporting requirements, including developing documented job aids that provide tangible guidance to investment managers on how to successfully meet new or recurring directives

K. Assist CPIC in supporting future agency projects in mapping (connecting the information dots) CPIC investments (See GFI Appendix B), IT capabilities and services, and Enterprise Architecture to strategic and other goals; identifying potential duplication between efforts across centers, investments or projects; and streamlining efforts, operations and resource expenditures.

3.4 CONSTRAINTS

Execution of Escalation Procedures

The contractor shall escalate issues related to any impediment to progress towards any deliverables defined in the IDIQ or an individual Task Order. The contractor shall follow escalation procedures consistent with the line of command in FDA. The contractor shall follow this order of escalation when reporting to FDA personnel:

1. Task Order Contracting Officers Representative (COR)

2. IDIQ COR

3. Contracting Officer

3.5 DEFINITIONS

CPIC - Capital Planning and Investment Control (CPIC) is the primary process for making investment decisions, assessing investment process effectiveness, and refining investment related policies and procedures.

FDA CPIC Staff – The OIM Staff responsible for oversight of the IT Investment Portfolio .

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DHHS CPIC Glossary - Specific to DHHS, these terms can be found at:

www.hhs.gov/ocio/about/terms/index.html. Official definitions for major, tactical and supporting IT investments, as well as other important information can be found at this site. This official information is subject to change, and the vendor shall work with the most current information as defined by FDA CPIC staff.

EPLC - Enterprise Performance Life Cycle (EPLC) is a framework to enhance Information Technology (IT) governance through rigorous application of sound investment and project management principles and industry’s best practices (See GFI APPENDIX F for a description of EPLC Artifacts).

Favorable scores – defined as “green” on itdashboard.gov, the U.S. Government official website for Agency IT dashboards. Deliverables are usually accepted by the government well in advance of when scores are posted, so acceptance shall be met long before a scoring is achieved. Favorable scores are a measure of Agency success and therefore of support vendor success. Extenuating circumstances that are outside the vendor control shall be documented and approved by CPIC or Investment Manager (as applicable), before an exemption of responsibility may be considered.

Investment Manager – A specific role in the CPIC process, in FDA the person responsible for the submission and content of a specific investment. While this is a “point” person, there is usually some amount of staff, contract or other support involved depending on the level of investment (i.e., major, tactical, supporting), but certainly constrained by the direction from the oversight ITIRB.

ITIM Information Technology Investment Management – FDA’s control process for approving new technology or nonstandard IT items, based on GAO best practices.

ITIRB - Information Technology Investment Review Board (ITIRB) implements an investment management process that drives budget formulation and execution for IT investments. FDA has and IRB at the Agency/Portfolio level, and at each Center/Investment level.

Program & Project Management – As a rule, FDA follows the Project Management Institute Project Management Body of Knowledge method. In addition, the Office of Management and Budget (OMB) has its own project management processes. The contractor shall need to understand and translate project management across both methods.

PROSIGHT - The HHS mandated Portfolio Management tool for IT portfolio and investment management is ProSight. The FDA uses this tool for IT required investment submissions to OMB through HHS. HHS owns, maintains and manages ProSight.

3.6 CONTRACT LEVEL PROGRAM MANAGMENT

The Contractor shall establish the program plans, structures, processes, schedules, reporting requirements, communication channels, and quality control functions necessary to steward the project throughout the contract’s period of performance and fully achieve contract objectives. The Contractor shall provide contract-level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones are met, this shall be documented in the draft Quality Assurance Plan (QAP) provided with the proposal. In addition the contractor shall provide a Risk Management Plan.

The Contractor shall provide a monthly contract level status report to the IDIQ COR, incorporating all tasks at a high level and their progress. Within the first 30 days after contract award, the Government http://www.hhs.gov/ocio/about/terms/index.html http://www.itdashboard.gov/

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and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:

• Summary status and progress of tasks, by task order and deliverable;

• Summary cost and schedule variances when applicable;

• Value added coordination activities across task orders;

• Impact or influence of task order performance on overall FDA mission

• Significant risks to scheduled deliverables across task orders and plans to mitigate them;

and,

• Percentage of work performed by the prime contractor as required by small business sub-contracting clause

3.7 DESCRIPTION OF WORK:

The contractor shall provide CPIC support throughout the FDA at governance and investment levels for all phases of the CPIC Process from Concept to Disposition and all related activities. In the task orders, the Contractor shall be required to do one or more of the following tasks:

Description of Task Areas

Task 1 – Contract Level Task Order Management Task 2 - Capital Planning and Investment Control – Oversight Support Task 3 - Capital Planning and Investment Control – Individual Investment Support Task 4 – Training

TASK 1 – CONTRACT LEVEL TASK ORDER MANAGEMENT

For the task orders released under this contract, the Contractor shall provide task order level project management to effectively manage tasks, monitor task order performance, manage contractor staff and provide subcontractor management; and establish notification mechanisms for acceptance by the government. For each task order, the Contractor shall prepare a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls, to include QAP as required in individual task orders, to be employed to meet the cost, performance and schedule requirements throughout task order execution.

To successfully conduct task order management the contractor task order manager may be requested to:

• Comply with reporting requirements as stipulated in the task orders.

• Follow escalation procedures for problems, issues, and recommendations as specified in individual task orders. Follow standard escalation procedures identified in Section 1.4 Constraints.

• Participate in FDA’s program/project reviews, EPLC stage gate reviews, management briefings, stakeholder presentations, and cross-agency information exchanges, in order to provide expert counsel to CPIC staff, collect and document lessons learned for the PMO repository, and to

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improve FDA’s CPIC scoring and other CPIC related outcomes as defined in individual Task Orders.

• Ensure compliance with FDA Enterprise Performance Lifecycle (EPLC) requirements for investment documentation as specified in individual task orders.

• Support FDA review processes for of IT investments.

TASK 2 - CAPITAL PLANNING AND INVESTMENT CONTROL (CPIC) OVERSIGHT SUPPORT

FDA Portfolio Assessment

The Portfolio Assessment is FDA’s key performance tool in the federal select-control-evaluate model.

FDA’s CPIC staff utilizes the assessment report to brief Enterprise Architecture about the status of investments in comparison to targeted architecture goals; identify the need to add, realign, or dispose investments; identify portfolio strengths/weaknesses; and identify the need for Corrective action. The Contractor shall work with the FDA to provide a comprehensive, detailed assessment of the current FDA portfolio. The TOs will provide tailored requirements for the portfolio assessment.

Develop and Support Implementation of Portfolio Improvement Plan

Implementation of approved Improvement Plans is vital to investment management. The CPIC oversight staff uses Improvement Plans to correct schedule, cost, and performance issues; execute corrective actions as directed by EA and Governance boards; ensure investments align with Agency’s strategic plans; and ensure investments comply with policy objectives, following approved best practices as applicable. The Contractor shall assist in developing and support implementing Portfolio Improvement Plans as directed in TOs.

CPIC Process and Control Support

The Contractor shall provide guidance to FDA Investment Managers, sharing guidance on how to properly manage, control, and report their investments in accordance with FDA’s internal controls and CPIC processes to include providing communication artifacts and presentation materials, for example job aids. The Contractor shall have demonstrated experience with ProSight or other similar portfolio management systems. Activities performed under this task are designed to: (1) provide legislative guidance and ensure that the FDA completes OMB and HHS requirements as needed and within deadlines; (2) provide schedule management to ensure the FDA community meets submission timelines (See GFI APPENDIX A for CPIC Timelines), activities, practices and policies (3) assist FDA CPIC staff with investment control management activities (4) Review EPLC investment documentation for completeness and report non-compliancy with references to CPIC staff and FDA investment Managers and (5) support development of accurate and high quality reports to inform executive management on portfolio activities.

TASK 3 – CAPITAL PLANNING AND INVESTMENT CONTROL (CPIC) INDIVIDUAL INVESTMENT SUPPORT

Exhibit 53/300 Development Support

The Contractor shall support the Center offices in the development of Exhibit 53s and Exhibit 300s to ensure timely submittal of high quality reports to OMB. The contract staff must demonstrate historical

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knowledge as well as document knowledge OMB rating schemes and will review and provide feedback on report content. The Contractor may facilitate capturing input to the reports. Thus, the Contractor shall periodically work closely with the agency IT investment portfolio offices to ensure the business priorities are conveyed, and the investment documentation meets FDA’s needs

Develop and Support Reporting Requirements

The Contractor shall work with the FDA Centers to support current reporting requirements. The FDA has proposed additional reporting data and an increase in the frequency of reporting to align with HHS and OMB requirements and improve portfolio management. The contractor shall support gathering and processing inputs into ProSight such as monthly reports, updates to performance measures and other items.

Develop and Support Investment Performance Metrics

The Contractor shall support the development and management of Investment performance metrics.

As part of this the contractor shall support the HHS CPIC policies that are in effect. Performance measures/metrics should be quantitative or qualitative, and clearly capture investment outcomes, and if applicable, investment outputs. They should support agency mission and strategic goals.

Task 4 -Training

The Contractor shall provide training and training support services in support of the FDA CPIC community. Training services may range from one-on-one sessions to development of new courses in addition the contractor may be required to provide training or communication materials as identified in the individual task orders based on needs of the CPIC staff, stakeholders, and program managers. The Contractor will meet CPIC deadlines for providing timely courses to ensure government employees and support contractors are able to maintain their required skill or knowledge levels. In response to significant training efforts, the Contractor shall develop and complete training plans and assessment tools to ensure that training objectives are met.

Training topics may include:

• Reporting requirements as they pertain to the OMB Circulars and Memoranda

• Exhibit 300 and why and/ how the report changes each year and how to respond

• How compliant program management practices can produce a compliant and “passing” Exhibit 300 as an “output”

• The importance of reporting in the manner mandated, and how to translate to other practices within programs and projects, to meet overall objectives applying CPIC to a program/project/investment; how and when does the requirement to complete an Exhibit 300/53 apply

• The role of government in Exhibit development and reporting versus that of a contractor (e.g., content ownership versus support)

• The role of cost & schedule to CPIC reporting and what impacts significant variances can cause in reporting

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SECTION 4: CONTRACT ADMINISTRATION DATA

4.1 FDA INVOICE REQUIREMENTS

The Contractor shall submit invoices as specified in each task order.

In general, to constitute a proper invoice, the invoice must be submitted on company letterhead and include-

(I) Name and address of the Contractor;

(II) Invoice date and invoice number;

(III) Contract Number and Task Order number;

(IV) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed;

(V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government Bill of Lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the task order or in a proper notice of assignment);

(VIII) Name, title, and phone number of person to notify in event of defective invoice;

(IX) Taxpayer identification number (TIN);

(X) Electronic funds transfer (EFT) banking information;

(XI) Name and telephone number of the FDA COTR referenced on the task order; and

(XII) Any other information or documentation required by the task order.

4.2 CONTRACTING OFFICER

The Contracting Officer for the IDIQ contract shall be identified post-award.

The Contracting Officer Representative (COR) executing the individual Task Order will retain cognizance of contract administration for each individual Task Order.

4.3 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) For the IDIQ Contract:

The COR will be designated after award for the IDIQ contract.

(b) For Task Orders:

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For each individual task order, a Task Order COR will be assigned. The TO COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The TO COR does not have 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 any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COTR designation.

Technical Leads may assist the COTR. The Technical Leads will not have the authority to provide technical direction in accordance with the paragraphs above; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during performance; and (6) reviewing of invoices/vouchers.

4.4 TECHNICAL DIRECTION

Performance of the work under this contract shall be subject to the technical direction of the Task Order COR. The term “technical direction: is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The TO COTR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract clause entitled: FAR 52.243-2

“Changes - Cost Reimbursement” (AUG 1987) – Alternate 1 – (APR 1984); FAR 52.243-1

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“Changes - Fixed Price” (AUG 1987) – Alternate 1 (APR 1984); or 52.243-3 “Changes – Time and Materials-Labor Hours” (SEP 2000).

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the TO COTR or shall be confirmed by him/her in writing within 5 working days after issuance.

If, in the opinion of the Contractor, any instruction or direction issued by the TO COTR is within one of the categories as defined above, the Contractor shall not proceed but shall notify the Task Order Contracting Officer (TOCO) in writing within 5 working days after the receipt of any such instruction or direction and shall request the TOCO to modify the contract, accordingly. Upon receiving such notification from the Contractor, the TOCO shall issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract. The Contractor shall proceed immediately with the instructions or directions and shall be subject to the provision of the contract clause entitled “Disputes.”

4.5 CONTRACTOR’S PRIMARY POINT OF CONTACT (POCs)

The Contractor shall submit a list of key POCs in their proposal.

4.6 TRAVEL COSTS

Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost in accordance with the Federal Travel Regulation..

(a) Area of Travel - Performance under this Agreement may require travel by contractor personnel. If travel, domestic, is required, the Contractor is responsible for making all needed arrangements for Contractor’s personnel. This includes but is not limited to the following:

• Medical Examinations

• Immunization

• Security Clearances

(b) Travel Policy - The Government will reimburse the Contractor for allowable travel costs incurred by the Contractor in performance of the contract and determined to be in accordance with FAR subpart 31.2, subject to the following provisions:

Travel required for tasks assigned under this contract shall be governed in accordance with rules set forth for temporary duty travel in FAR 31.205-46.

(c) Travel - Travel, subsistence and associated labor charges for travel time are authorized, whenever a task assignment requires work to be accomplished at a temporary alternate worksite. Travel performed for personal convenience and daily travel to and from work at Contractor’s facility will not be reimbursed.

(d) Per Diem - Per diem for travel on work assigned under this contract will be reimbursed to employees consistent with company policy, but not to exceed the amount authorized in the Federal Travel Regulations.

(e) Air/Rail Travel - In rendering the services, the Contractor shall be reimbursed for the actual costs of transportation incurred by its personnel not to exceed the cost of tourist class rail, or plane fare, to the

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extent that such transportation is necessary for the performance of the services hereunder and is authorized by the Contracting Officer. Such authorization by the Contracting Officer shall be indicated in the order or in some other suitable written form.

NOTE: To the maximum extent practicable without the impairment of the effectiveness of the mission, transportation shall be tourist class. In the event that only first class travel is available, it will be allowed, provided justification therefore is fully documented and warranted.

(f) Private Automobile - The use of privately owned conveyance within the continental United States by the traveler will be reimbursed to the Contractor at the mileage rate allowed by Joint Travel Regulations.

Authorization for the use of privately owned conveyance shall be indicated on the order. Distances traveled between points shall be shown in standard highway mileage guides. Any deviations from distance shown in such standard mileage guides shall be explained by the traveler on the expense sheet.

(g) Car Rental - The Contractor shall be entitled to reimbursement for car rental, exclusive of mileage charges, as authorized by each order, when the services are required to be performed outside the normal commuting distance from the Contractor’s facilities. Car rental for TDY teams will be limited to a rate of one car for every four (4) persons on TDY at one site.

4.7 OTHER DIRECT COSTS (ODC)

Any Other Direct Costs (ODC) should be submitted through the invoice. All ODC over $3,000, other than those ODC acquired under the firm fixed price line items, must be pre-approved by the Contracting Officer, if not already approved through the issuance of a task order or modification.

To be eligible to receive reimbursement for ODC the Contractor must obtain at least three quotes for each transaction in excess of $3,000.00 to ensure that adequate price competition was sought or the Contractor must provide an acceptable justification as to why it was impracticable to do so. For purchases of ODC, the Contractor needs to provide the aforementioned documentation only when requested by the Contracting Officer.

The Contractor shall maintain documentation of all reimbursable purchases until three years after the contract is completed and shall provide access to and copies of such documentation when requested by the Contracting Officer.

The Contracting Officer may reduce the reimbursement by any amount above that which the Contracting Officer funds, in his/her sole discretion, is greater than that which is fair and reasonable for the ODC giving due consideration to the facts and circumstances prevailing at the time that the Contractor procured the ODC. Disputes as to the amount by which any reimbursement is reduced shall be resolved in accordance with the “Disputes” clause of the contract. It shall be the Contractor’s burden to demonstrate that the price it paid for the reimbursable items was fair and reasonable.

4.8 GOVERNMENT FURNISHED PROPERTY (GFP)

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The Government reserves the right to furnish property to the Contractor for use under the contract, when it determines that it is in the Government’s best interest to do so. Notwithstanding the Government’s decision to furnish such property, the Contractor shall have the capability to furnish all materials and equipment necessary for the performance of the work required under this contract, including the test, evaluation, and demonstration of products used under this contract.

All GFP shall be managed and maintained in accordance with the Government Furnished Property clauses specified in Sections 6 and 7 of this contract.

4.9 CORRESPONDENCE PROCEDURES

To promote timely and effective administration, correspondence (except for invoices), submitted under this contract or subsequent task orders shall be subject to the following procedures:

a) Technical Correspondence – Technical correspondence (as used herein, this term excludes correspondence which proposes or otherwise involves waivers, deviations or modifications to the requirements, terms or conditions of this contract) shall be addressed to the Task Order COTR/Technical Lead (TL) with an informational copy of the basic correspondence to the COTR for the IDIQ contract..

b) Other Correspondence – All other correspondence shall be addressed to the CO/TOCO, in duplicate, with an informational copy of the basic correspondence to the IDIQ COTR/TO COTR/TL, as applicable.

c) Subject Lines – All correspondence shall contain a subject line, commencing with the contract number and assigning consecutive numbers (serial numbers to permit accountability), as illustrated below:

EXAMPLE: Contract No.-500-00-XXXX, Task Order No. XX Sequence # - XX(YEAR) - XXXX Subject - Request for Subcontract Consent

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SECTION 5: REQUESTING, PLACING, AND PROCESSING ORDERS

5.1 GENERAL TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order. A task order shall be “issued” for purposes of this contract upon the effective date of the order.

The Contractor is required to analyze and bring to the Contracting Officer’s attention any major impact the particular task will have on prior tasks and how the task fits into the overall CPIC Program.

5.2 AUTHORIZED ORDERING OFFICIALS

U.S Department of Food and Drug Administration, Office of Acquisitions & Grant Services Contracting Officers are authorized as ordering officials to place task orders under this contract.

5.3 ORDERING PROCESSES AND PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Section I entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

5.4 TASK ORDER PROCESSING

The general process for individual task orders is as follows:

When a need for services within scope of this contract arises, the FDA will issue a Request for Task Order Proposal (RFTOP). The process for awarding tasks orders will be as follows:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and Deliverables

Requests for Task Order Proposals (RFTOP) shall only be issued by the Contracting Officer.

The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

B. The Government will determine the most appropriate task order type for each effort. The Contractor shall propose in accordance with the task order type specified by the Contracting Officer (CO) in the

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Request for Task Order Proposal (RFTOP). The Contractor shall perform in accordance with the task order type selected by the CO indicated in the award document of other authorized award notification.

E. Task order proposals shall consist of a brief management and technical section, and cost/price proposal.

1. The management and technical proposal should identify the Contractor’s proposed approach to the specific task. The Contractor’s proposal should address the number(s) of personnel performing each task; number of hours each individual will work with an explanation of why each is necessary to perform the task order; the rationale for the personnel, skill levels, and number of hours proposed;

and an overall discussion of the Contractor’s proposed technical solution. Any government property, material, or data required for performance must be identified in the response to the RFTOP. The Contractor shall further identify and provide rationale for the NAICS code assigned for subcontracted work.

2. Cost/price proposal: Labor costs must be broken out by labor category, proposed hours and loaded fixed price labor rates (identified in Section B). The proposal shall consider and reflect pre-negotiated labor rate changes for subsequent periods (See Section B). Also include applicable indirect rates for travel, materials, and subcontracting.

F. If a firm-fixed price (FFP) task order is contemplated as a result of issuance of a RFTOP, contractors will be required to prepare a FFP proposal and include other costs (e.g., material, travel) as well as profit. The Government shall evaluate the overall price for each fixed price CLIN identified in the RFTOP.

However, to facilitate the technical evaluation, the Contractor may be asked to provide a breakout of the labor categories, descriptions, and hours for personnel proposed.

G. The Government may issue task orders with option periods when it is determined appropriate in accordance with FAR 17.2. A task order with options shall be evaluated in accordance with FAR 52.217- 5, Evaluation of Options.

Content of Order: Each task order placed under this contract shall include the following minimum information:

1. The contract number, task order number, and date of order

2. Applicable accounting and appropriation data, and special invoicing instructions where applicable.

Additional information can include:

a) Item number and description, quantity and unit price.

b) Cost and hours (as negotiated), extended amounts, fee (if applicable), total estimated amount, and reporting requirements.

c) Delivery or performance date.

d) Place of delivery or performance (including consignee)

e) Packaging, packing, and shipping instructions, if any

f) Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

g) Individual orders will reflect the requirement of particular circumstances as applicable.

Urgent orders will cite peculiar terms and requirements.

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H. EMERGENCY ORDERS –In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the Contracting Officer may verbally authorize performance to commence immediately so long as the work to be performed in the emergency situation is within the scope of this contract. In those instances, a written work plan shall be submitted with 10 calendar days following the authorization to commence work. When work is authorized to commence prior to the submission and negotiation of a work plan, the contracting Officer will indicate at time of authorizing work a dollar ceiling that may not be exceeded except at the Contractor's own risk.

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SECTION 6: SPECIAL CONTRACT REQUIREMENTS

6.1 DISCLOSURE OF INFORMATION

Contractors are reminded that information furnished under this solicitation and resulting contracts and task orders may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information must be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA.

However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government must be used only for the purpose of carrying out the provisions of this contract and must not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of this contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. §

641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

6.2 CONTRACTOR PERFORMANCE EVALUATIONS

Interim and final evaluations of Contractor performance will be prepared on this IDIQ contract and subsequent task orders in accordance with FAR Subpart 42.15. A final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the contract. FDA uses the Contractor Performance Assessment Reporting System (CPARS) to fulfill FAR requirements to evaluate contract performance, which can be found at http://www.cpars.csd.disa.mil/ Contractors are required to register on this site to receive and comment on performance evaluations.

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 (30) days to review the document and to submit additional information or a rebutting statement. Any disagreement between the parties regarding an evaluation 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.

http://www.cpars.csd.disa.mil/

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6.3 METHODS OF OPERATION

The Contractor shall provide sufficient oversight of the contract in order to ensure that:

a. All employees are functioning within their designated labor categories and at acceptable levels of performance.

b. All activities performed are covered by applicable Task Orders and directly related to Section C Statement of Work (SOW). Time spent on non-project related activities must not be billed to the Government.

c. Employee positions called for are filled promptly (i.e., within 15 business days of contract award) and kept filled with qualified, competent personnel. No personnel matters such as recruiting, reviewing resumes, and initial interviewing as well as Contractor (Corporate) meetings are directly billable to the Government.

d. All Contractor employees are performing their designated assignments in a timely manner and all reporting requirements are honored.

e. All Contractor employees have been trained in proper office procedures as pertains to business professionals.

f. All Contractor employees receive on-going technical training as described in the Offeror’s proposal.

6.4 ORGANIZATIONAL CONFLICTS OF INTEREST

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

Contractors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions.