AttachmentB.doc

SOLICITATION ATTACHMENT #B

10-223-SOL-00051

10-223-SOL-00051

SECTION 1.0: STATEMENT OF WORK (SOW)

Title: Rational RequisitePro Annual Software license and Maintenance Support Renewal

1.0 Background

The Food and Drug Administration, (FDA) uses Rational RequisitePro to help project teams manage their requirements. Requirements management is an important step in the Enterprise Performance Life Cycle (EPLC) model used by FDA. The Requirements Management Process encompasses tracking of requirements status, base-lining requirements, managing changes to the requirements baseline and versions of requirements specifications, and tracing individual requirements to work products. Requirements management begins with the identification of high-level functional and non-functional requirements in the System Boundary Document during the System Concept Development phase of the System Development Life Cycle (SDLC). Identification, documentation, and management of requirements continue throughout the system’s life cycle.

Currently, the Rational Requisite Pro tool (version 6.1 and 7.0) and Software Document Automation (SoDA) are being used for managing, tracking, and reporting on the status of requirements for the FDA projects. Rational RequisitePro was purchased with Twenty-Five (25) floating licenses.

2.0 Objective

The objective of the contract is to renew current licenses and provide support maintenance for Rational RequisitePro and SoDA, in order to manage the complexity of project requirements of FDA software development systems.

3.0 Scope

The FDA is seeking qualified sources capable of providing IBM Rational Requisite Pro Licenses, and Technical Support / Maintenance for the Rational Requisite Pro and SODA Float Licenses or equal to.

4.0 Specific Tasks/Deliverables

BASE PERIOD:

4.1 STEADY STATE ACTIVITIES

Steady State Task 1: Renew Maintenance Coverage on our existing 25 Rational RequisitiePro Licenses (Part Number: D5326LL) Renewal of support maintenance for our Rational RequisitePro includes but not limited to the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, SoDA, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro, SoDA, and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

Steady State Task 2: 1 Renewal of Support and Maintenance onSoftware Document Automation (SoDa) License and Maintenance Support:

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

Steady State Task 3: 15 New Rational Pro Licenses and Maintenance Support

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, BIRT tools. It includes conversion of SoDA reports to BIRT reports. Troubleshooting, interface and integration of RationalPro and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

OPTION PERIOD 1:

STEADY STATE ACTIVITIES:

Steady State Task 1: Renew Maintenance Coverage on 40 existing Rational Requisitie Pro Licenses.

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, SoDA, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro, SoDA, and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

Steady State Task 2: Renew Maintenance coverage on one existing Software Document Automation (SoDa) License;

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

OPTION PERIOD 2:

STEADY STATE ACTIVITIES:

Steady State Task 1: Renew Maintenance Coverage on 40 existing Rational Requisitie Pro Licenses.

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, SoDA, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro, SoDA, and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

Steady State Task 2: Renew Maintenance coverage on one existing Software Document Automation (SoDa) License;

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

OPTION PERIOD 3:

STEADY STATE ACTIVITIES:

Steady State Task 1: Renew Maintenance Coverage on 40 existing Rational Requisitie Pro Licenses.

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, SoDA, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro, SoDA, and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

Steady State Task 2: Renew Maintenance coverage on one existing Software Document Automation (SoDa) License;

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

OPTION PERIOD 4:

STEADY STATE ACTIVITIES:

Steady State Task 1: Renew Maintenance Coverage on 40 existing Rational Requisitie Pro Licenses.

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, SoDA, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro, SoDA, and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

Steady State Task 2: Renew Maintenance coverage on one existing Software Document Automation (SoDa) License;

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

4.2 INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ)

The following tasks are included in this Statement of Work but cannot be defined in sufficient detail at this time since they are either “as needed” or “one-time-only” tasks. The IDIQ activities and funding for the activities will vary from year to year. FDA anticipates awarding 2-3 tasks against this line item per year. The Contracting Officer's Technical Representative (COTR) will direct these tasks based on the program priorities and funding available. The Government will determine the most appropriate task order type (fixed price or time and materials) for each effort. The Contractor shall be expected to perform the following services and possible additional tasks that are considered work within scope of the contract:

IDIQ Task 1: On-site Maintenance services for Rational RequisitePro, as directed by COTR, includes but not limited to the followings:

· IBM Rational professional services;

· Administration of Rational ReqPro which includes but not limited to knowledge transfer of administrative activities and documentation for web client and different components of ReqPro;

· Emergency Maintenance and operation of ReqPro tool suite including data backup recovery;

IDIQ Task 2: Purchase of additional licenses and Maintenance Support of additional Rational RequisitePro includes but not limited to the followings;

New licenses and keys (Part Number: D5326LL; Part Number: D532PLL) Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro, BIRT tools. It includes conversion of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and BIRT tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for ReqPro and its components;

IDIQ Task 3: Purchase of additional licenses and Maintenance Support of SoDA licenses.

Maintenance Support should include the following:

· Major product and technology releases;

· Standard Product technical support, which typically includes On-Call phone and online support M-F, 8am-4:30pm. Standard technical support includes but not limited to day-to-day support for admin activities, ReqPro and SoDA tools. It includes conversion and integration of SoDA reports to BIRT reports.

· Troubleshooting, interface and integration of RationalPro and SoDA tools with other testing tools shall be provided by the contractor;

· Standard IBM Maintenance which includes: Updates, fixes, security alerts, datafixes, and critical patch updates released throughout the term of the support contract;

· Standard Upgrading of scripts or tools released throughout the term of the support contract;

· Technical assistance for SoDA and its components;

IDIQ Task 4: Migration of repositories from ReqPro 6.x to 7.x.

Support is needed in the migration of repositories from RequisitePro 6.x to 7.x. A maximum of 30 projects need to be migrated. The project size ranges from 350KB to 117MB, and the average size is 17MB.

IDIQ Task 5: Migration of SoDA reports to BIRT Support is needed in the migration of SoDA reports to BIRT. Typically, each project Use

Case has a SoDA report, and those reports will need to be migrated to BIRT. There are a maximum of 100 reports.

IDIQ Task 6: On-site Training on Rational Pro Software The Rational Pro Software training shall provide instruction on the use of Rational Requisite

Pro, a tool for capturing and managing requirements for a project. The training shall provide an understanding of the Requisite Pro project structure and use of the tool to apply software development best practices. One training class pertaining to Requisite Pro administration is needed (maximum 10 people), and multiple training classes are needed for general Requisite

Pro use (maximum 30 people in year 1, and maximum 10 people in subsequent years).

IDIQ Task 7: On-site Training on SoDA Software The SoDA Software training shall provide instruction on the use of the SoDA, a report generation tool that supports reporting as well as a formal documentation requirements. The training shall provide an understanding of how the tool interfaces with the Rational software in designing custom reports and documents. One training class (maximum 10 people) is needed in SODA, and one training class (maximum 10 people) is needed in BIRT.

SECTION 2.0: DELIVERIES OR PERFORMANCE

Place of Performance

The support for the Steady state work shall be performed at the contractor’s site which typically includes On-Call phone and online support M-F 8:00 AM to 4:30 PM. The support for the IDIQ work should be performed at the FDA Washington DC metro area facilities at 2094 Gaither Road, Rockville, MD 20850 or 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Period of Performance

Base Year: April 1, 2010 – March 31, 2011 Option Year 1: April 1, 2011 – March 31, 2012 Option Year 2: April 1, 2012 – March 31, 2013 Option Year 3: April 1, 2013 – March 31, 2014 Option Year 4: April 1, 2014 – March 31, 2015

HOURS OF OPERATION:

The contractor shall provide standard product on-call and online service between 8:00 a.m. and 4:30 p.m. Eastern Time, Monday through Friday, excluding Federal holidays and building closures.

OBSERVANCE OF FEDERAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS:

Coverage is expected during all Federal work days. Services typically will not be performed at the Federal site when the federal government is closed for reasons such as inclement weather or executive order. Typically, no services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below unless specifically requested by the COTR (in the best interest of industry coverage).

1.

New Year’s Day January 1st 2.

Martin Luther King Day Third Monday in January

3.

President’s Day Third Monday in Feb.

4.

Memorial Day

Last Monday in May

5.

Independence Day July 4th

6.

Labor Day

First Monday in Sept.

7.

Columbus Day Second Monday in Oct.

8.

Veteran’s Day

November 11

9.

Thanksgiving Day Fourth Thursday in Nov.

10.

Christmas Day December 25

SECTION 3.0 - CONTRACT ADMINISTRATION DATA

GOVERNMENT POINTS OF CONTACT

A. Address and Telephone number of the Contracting Staff:

Contracting Officer:

Contract Specialist:

Jody O'Kash

Brendan McCarthy 5630 Fishers Lane, RM 2003

Phone: 301-827-4680

Rockville, MD 20857

Email: Brendan.McCarthy@fda.hhs.gov Phone: (301) 827-5094

Email: Jody.O'Kash@fda.hhs.gov

Contracting Officer’s Authority

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this Order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO, including work outside the scope of the contract.

Contracting Officer's Technical Representative (COTR):

A Government Contracting Officer's Technical Representative (COTR) will be responsible for the overall success of the project, ensuring adequate coordination among the various management components. The COTR is designated to monitor the performance of this contract on behalf of the Government. He/She will provide no supervisory or instructional assistance to Contractor personnel regarding the application software. The COTR’s function is primarily to provide the Contractor with working data. He/She is not empowered to make any commitments or authorized to make any changes that affect process, terms or delivery as specified in this order. Any such proposed changes shall be brought to the immediate attention of the CO for action. The acceptance of any changes by the Contractor without specific approval and written consent of the CO shall be at the contractor’s own risk. The following person haS been appointed as the COTR:

To be disclosed at time of award

CONTRACTOR’S CONTRACT ADMINISTRATION

The Contractor’s contract administration functions will be performed at the following address:

To be disclosed at time of award

BILLING INSTRUCTIONS

A.

In accordance with FDA's two-way method for processing invoices for Time and Material / Labor Hour Performance Based Contracts and FAR 52.232-25, Prompt Payment, the contractor must submit monthly invoices by mail and electronically to the Contract Specialist.

B.

All invoices must include the following information:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Purchase order number and line item numbers and;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(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;

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

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this order.

(x) Electronic funds transfer (EFT) banking information.

(xi)DUNS number.

C. The contractor shall submit a Release of Claims for final order and modification invoices (including final invoices for each option period)

NOTIFICATION REGARDING ADMINISTRATIVE PROBLEMS

If at any time during the performance of this contract, administrative problems should arise which will have an adverse impact on timely performance by the Contractor or affect the contract costs or funding, the Contractor is required to immediately notify the Contracting Officer (CO) identified and the cognizant Contract Specialist identified in paragraph above.

SECTION 4.0 - SPECIAL CONTRACT REQUIREMENTS

Pricing Terms – Fixed price Items

The unit prices proposed for each line item are fixed price unit prices and include all applicable labor, overhead, general, travel, and administrative expense, and profit.

Pricing Terms – IDIQ Task / Delivery Orders

1. The labor rates proposed for each item/subitem are fixed prices and include all applicable labor, overhead, general and administrative expense, and profit.

2. For Time and Material (T&M) priced task orders issued under this contract, the applicable order labor rate for a task order shall be the labor rate 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 labor rates specified in a T&M task orders shall be fixed for that order 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 work identified in the task order within the time specified in the task order. In the event of any such Government caused delay, the contractor shall, within ten (10) calendar days after delay, notify the Contracting Officer and submit to the Contracting officer a cost quote for any resulting cost and/or schedule impact. However, in no event shall the contractor perform, or be paid for any work which exceeds the no-to-exceed dollar amount of a T&M order.

3. For Firm Fixed price (FFP) priced delivery orders issued under this contract, the total price for the order shall include all applicable labor, overhead, general, travel, and administrative expense, and profit.. The price(s) specified in FFP priced delivery orders issued under this contract is/are fixed and not subject to adjustment.

4. The contractor may propose cost for travel, material, equipment, and related supplies for time and material task orders. The cost of travel for fixed priced delivery orders must be included in the overall fixed price.

5. The handling charge rates (if applicable) shall be fixed percentage rates (applicable to IDIQ line item only).

Cost Reimbursable Travel Expenses NOTE: Applies to IDIQ line item only. The contractor shall be reimbursed for all reasonable local and remote travel as identified in T&M task orders placed against this contract, and accepted by the COTR and CO. The travel to be reimbursed shall not exceed the travel ceilings specified in the Federal Travel Regulations. Travel by motor vehicle including rented automobile shall be reimbursed on a mileage basis at the current rate established by the Federal Travel Regulations, plus any toll, parking expenses, and public transportation expenses.

The Contractor shall invoice and be reimbursed for all travel costs associated allowable and allocable to the DBA Contract. All costs shall be on a cost-reimbursable basis and shall be in accordance with Federal Acquisition Regulations (FAR) 31.205-46, Travel Costs. Please check the following website for authoized per diem rates:

http://www.gsa.gov/Portal/gsa/ep/contentView.docontentId=17943&contentType=GSA_BASIC. No profit or fee is allowed on travel, material, or other direct costs.

Requesting, Placing, and Processing Orders NOTE: Applies to IDIQ Line Item Only

A. Authorized Ordering Activities: The Contracting Officer of the Food and Drug Administration may place orders under this contract. Except as may be otherwise specifically stated herein, wherever the words, “Contracting officer” are used in the schedule of this contract, they shall be deemed to mean the Contracting Officer of the ordering activity, of which the Contracting Officer has full responsibility for administering all contractual actions arising from any task order issued by the ordering activity.

The Contracting Officer, or his/her representative, whose signature appears on this contract, has the sole responsibility and authority to make any changes to the provisions of this contract.

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 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.

C. When the Government has a requirement for work to be performed the CO will notify the contractors of: (1) the work to be performed; (2) the desired performance period; and (3) any other information considered to be of assistance to the Contractor in preparing a proposal. The RFTOP will be written and may be transmitted by any means including mail, e-mail, facsimile or Internet. The standard method of transmission will be e-mail or the Internet.

D. The RFTOP shall not obligate the Government to issue task orders under this contract nor shall it authorize the Contractor to perform any work pursuant to such requests for proposal prior to the Contractor’s receipt of a task order.

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:

1. Item number and description, quantity and unit price.

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

3. Delivery or performance date.

4. Place of delivery or performance (including consignee)

5. Packaging, packing, and shipping instructions, if any

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

7. Individual orders will reflect the requirement of particular circumstances as applicable. Urgent orders will cite peculiar terms and requirements.

H. Issuing Orders and Modifications: The Ordering Officer and the contractor shall reach agreement on material terms of each order or order modification prior to its issuance. Under emergency situations, the Contractor may be given verbal authorization to begin work with a not to exceed amount, with a definitized order to be issued later.

I. Processing of Orders by the Contractor: Within fifteen (15) days after receipt of each order hereunder, or within such additional period as the Contracting Officer may allow, the Contractor shall sign and return 1 copy of the order to the Contracting Officer.

J. Order Amount: Orders may be fully funded or incrementally funded (Time and Material Orders ONLY). If fully funded, the price of an order constitutes the not to exceed ceiling of that order. If incrementally funded, the price of the amount funded constitutes the not to exceed cost ceiling for that order.

K. Costing of Orders: The Contractor warrants that the costs charged under this contract shall not exceed the costs charged by the Contractor to its most favored customers for like items or services under comparable conditions.

Security

This Statement of Work (SOW) requires the contractor to (1) develop, (2) have the ability to access, or (3) host and/or maintain a Federal information system(s). Pursuant to Federal and HHS Information Security Program Policies, the contractor and any subcontractor performing under this task order shall comply with the following requirements:

Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002); http://csrc.nist.gov/policies/FISMA-final.pdf.

Information Type

[x] Administrative, Management and Support Information:

Information Management

Lifecycle/Change Management

Record Retention

Budget and Finance

Reporting and Information [x] Mission Based Information:

Consumer Health and Safety

Security Categories and Levels Confidentiality Level:

[ ] Low [x] Moderate [ ] High

Integrity Level:

[ ] Low [x] Moderate [ ] High

Availability Level:

[x] Low [ ] Moderate [ ] High

Overall Level:

[ ] Low [x] Moderate [ ] High

Position Sensitivity Designations

i. The following position sensitivity designations and associated clearance and investigation requirements apply under this task order.

[x] Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or LBI). Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a National Agency Check and Inquiry Investigation plus a Credit Check (NACIC), a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

ii. The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the task order that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the task order. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer shall notify the contractor of the appropriate level of suitability investigations to be performed. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: http://ais.nci.nih.gov/forms/Suitability-roster.xls.

Upon receipt of the Government's notification of applicable Suitability Investigations required, the contractor shall complete and submit the required forms within 30 days of the notification.

Contractor/subcontractor employees who have met investigative requirements within the past five years may only require an updated or upgraded investigation.

iii. Contractor/subcontractor employees shall comply with the HHS criteria for the assigned position sensitivity designations prior to performing any work under this task order. The following exceptions apply:

7.3.3.1. Levels 5 and 1: Contractor/subcontractor employees may begin work under the task order after the contractor has submitted the name, position and responsibility of the employee to the Project Officer, as described in subparagraph c. (2) above.

7.3.3.2. Level 6: In special circumstances the Project Officer may request a waiver of the pre-appointment investigation. If the waiver is granted, the Project Officer will provide written authorization for the contractor/subcontractor employee to work under the task order.

Information Security Training

The contractor shall assure that each employee has completed the FDA Computer Security Awareness Training (http://www.useraware.com) prior to performing any work under this task order.

The contractor shall maintain a listing by name and title of each individual working under this task order that has completed the required security training. Any additional security training completed by contractor staff shall be included on this listing. [The listing of completed training shall be included in the first technical progress report. (See SOW status reporting requirements.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.]

Offeror's Official Responsible for Information Security

The offeror shall include in the "Information Security" part of its Technical Proposal the name and title of its official who will be responsible for all information security requirements should the offeror be selected for an award.

Personnel Security Responsibilities

The contractor shall perform and document the actions identified in the "Employee Separation Checklist" (http://nitaac.nih.gov/downloads/ciosp2/Employee_Separation_Checklist.doc) when a contractor/subcontractor employee terminates work under this contract. All documentation shall be made available to the Project Officer and/or Contracting Officer upon request.

Commitment to Protect Non-Public Departmental Information Systems and Data

iv. Contractor Agreement

The Contractor and its subcontractors performing under this SOW shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information:

-18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)

-18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

-Public Law 96-511 (Paperwork Reduction Act)

v. Contractor-Employee Non-Disclosure Agreements

Each contractor/subcontractor employee who may have access to non-public Department information under this task order shall complete the Commitment to Protect Non-Public Information - Contractor Agreement (http://nitaac.nih.gov/downloads/ciosp2/Contractor_Employee_Non-Disclosure.doc). A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer prior to performing any work under the contract.

Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the task order. The Government has determined that the information/data that the Contractor will be provided during the performance of the task order is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Government Furnished Equipment (GFE)/ Government Furnished Information (GFI)

FDA will provide Laptops, tokens (fobs), and any essential accessories along with FDA network access to all members under this contract for maintenance and technical support activities if contractor needs to connect to FDA network.

FDA will provide server based environment necessary to run the requested software Government-furnished Information/Reference Materials.

The information provided by the Government will be collectively known as the knowledge base. The Government retains ownership over this information. This includes, but is not limited to, policies, procedures, resolutions including escalation routing information, any lists of users, addresses, and roles, any instructions for the help desk as a whole or for individual applications that have not been incorporated into the automatic lookup tool, and any Tier 0 data if separate from the automated lookup tool.

Provisions must be included (as part of the security plans) to protect this information from unauthorized dissemination.

The format for return of this information at the termination of this contract will be agreed upon at that time.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCEtc \l 3 "ARTICLE G. . POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE" Contractor Performance Evaluations

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 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) shall be submitted annually.

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.

HHSAR CLAUSES

352.202-1 DEFINITIONS (January 2006)

(a) In accordance with 52.202–1(a)(1), substitute the following as paragraph (a):

‘‘(a) The term ‘‘Secretary’’ or ‘‘Head of the Agency’’ (also called ‘‘Agency Head’’) means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ‘‘his/her duly authorized representative’’ means any person, persons, or board authorized to act for the Secretary.’’

(b) In accordance with 52.202–1(a)(1), add the following paragraph (h):

‘‘(h) The term ‘‘Project Officer’’ means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.’’

(End of clause)

352.232-9 WITHHOLDING OF CONTRACT PAYMENTS (January 2006)

Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays’’ or ‘‘Default’’, as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

(End of clause)

352.249-14 EXCUSABLE DELAYS (January 2006)

(a) Except with respect to failures of subcontractors, the Contractor shall not be considered to have failed in performance of this contract if such failure arises out of causes beyond the control and without the fault or negligence of the Contractor.

(b) Such causes may include, but are not restricted to, acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Contractor. If the failure to perform is caused by the failure of a subcontractor to perform, and if such failure arises out of causes beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either of them, the Contractor shall not be deemed to have failed in performance of the contract, unless:

(1) The supplies or services to be furnished by the subcontractor were obtainable from other sources,

(2) The Contracting Officer ordered the Contractor in writing to procure such supplies or services from such other sources, and

(3) The Contractor failed to comply with such order. Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of such failure and if the Contracting Officer determines that any failure to perform was caused by circumstances beyond the control and without the fault or negligence of the Contractor, the delivery schedule shall be revised accordingly, subject to the rights of the Government under the termination clause contained in this contract. (As used in this clause, the terms ‘‘subcontractor’’ and ‘‘subcontractors’’ mean subcontractor(s) at any tier.)

(End of clause)

352.270-4 PRICING OF ADJUSTMENTS (Jan. 2001)

When costs are a factor in determination of a contract price adjustment pursuant to the “Changes” clause or any provision of this contract, such costs shall be determined in accordance with the applicable cost principles and procedures set forth below:

Principles

Types of organizations

(a) Subpart 31.2 of the Federal

Commercial.

Acquisition Regulation.

(b) Subpart 31.3 of the Federal

Educational.

(c) Subpart 31.6 of the Federal

State, local, and federally

Recognized Indian tribal governments.

(d) 45 CFR Part 74 Appendix E

Hospitals (performing research and development contracts only.

(e) Subpart 31.7 of the Federal

Other nonprofit institutions. Acquisition Regulation.

(End of clause)

352.270-5 KEY PERSONNEL (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)

352.270-6 PUBLICATIONS AND PUBLICITY (January 2006)

(a) Unless otherwise specified in this contract and the Confidentiality of Information clause is included, the Contractor is encouraged to publish the results of its work under this contract. A copy of each article submitted by the Contractor for publication shall be promptly sent to the Project Officer. The Contractor shall also inform the Project Officer when the article or other publication is published, and furnish a copy of it as finally published.

(b) The Contractor shall include in any publication resulting from work performed under this contract a disclaimer reading as follows:

‘‘The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences, do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.’’

(c) Unless authorized by the Project Officer, the contractor shall not display the HHS logo on any conference materials or publications.

(End of clause)

352.270–10 ANTI LOBBYING (January 2006)

Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

(End of clause)

352.270–13 TOBACCO FREE FACILITIES (January 2006)

In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with this policy.

(End of clause)

SECTION 5.0: CONTRACT CLAUSES

FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

52.212-4, Contract Terms and Conditions - Commercial Items (MAR 2009)

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (DEC 2009)

52.222-50, Combating…