10-223-SOL-00188 RFP Amendment 1.pdf

SF1449 – Pricing Schedule

Item

Number

Item Description Qty Unit Unit Price Amount

0001 SOW Task 4.1 (Optional) (Labor Hour)

Contract Transition Activities

1 Lot

0002 SOW Task 4.2 (FFP) – Base Period

Hosting Services

12 Month

0003 SOW Task 4.3 (FFP) – Base Period

Web Caching Services & Support

12 Month

0004 SOW Task 4.4 (Labor Hour) – Base Period

Search Services

1 Lot

0005 SOW Task 4.5 (Labor Hour) – Base Period

Web Content Management System

1 Lot

0006 SOW Task 4.6 (FFP) – Base Period

Web Application Maintenance &

Enhancements

12 Month

0007 SOW Task 4.7 (FFP) – Base Period

Project Management Support

12 Month

0008 SOW Task 4.8 (Labor Hour) Base Period

Web Development and Maintenance for the

Center for Tobacco Products

1 Lot

0009 SOW Task 4.9 (Labor Hour) Base Period

Web Development and Maintenance for the

Office of Regulatory Affairs

1 Lot

1001 SOW Task 4.2 (FFP) – Option Period 1

Hosting Services

12 Month

1002 SOW Task 4.3 (FFP) – Option Period 1

Web Caching Services & Support

12 Month

1003 SOW Task 4.4 (Labor Hour) – Opt Period 1

Search Services

1 Lot

1004 SOW Task 4.5 (Labor Hour) – Opt Period 1

Web Content Management System

1 Lot

1005 SOW Task 4.6 (FFP) – Option Period 1

Web Application Maintenance &

Enhancements

12 Month

1006 SOW Task 4.7 (FFP) – Option Period 1

Project Management Support

12 Month

1007 SOW Task 4.8 (Labor Hour) Opt Period 1

Web Development and Maintenance for the

Center for Tobacco Products

1 Lot

1008 SOW Task 4.9 (Labor Hour) Opt Period 1

Web Development and Maintenance for the

Office of Regulatory Affairs

1 Lot

2001 SOW Task 4.2 (FFP) – Option Period 2

Hosting Services

12 Month

2002 SOW Task 4.3 (FFP) – Option Period 2

Web Caching Services & Support

12 Month

2003 SOW Task 4.4 (Labor Hour) – Opt Period 2

Search Services

1 Lot

2004 SOW Task 4.5 (Labor Hour) – Opt Period 2

Web Content Management System

1 Lot

2005 SOW Task 4.6 (FFP) – Option Period 2

Web Application Maintenance &

Enhancements

12 Month

2006 SOW Task 4.7 (FFP) – Option Period 2

Project Management Support

12 Month

2007 SOW Task 4.8 (Labor Hour) Opt Period 2

Web Development and Maintenance for the

Center for Tobacco Products

1 Lot

2008 SOW Task 4.9 (Labor Hour) Opt Period 2

Web Development and Maintenance for the

Office of Regulatory Affairs

1 Lot

3001 SOW Task 4.2 (FFP) – Option Period 3

Hosting Services

12 Month

3002 SOW Task 4.3 (FFP) – Option Period 3

Web Caching Services & Support

12 Month

3003 SOW Task 4.4 (Labor Hour) – Opt Period 3

Search Services

1 Lot

3004 SOW Task 4.5 (Labor Hour) – Opt Period 3

Web Content Management System

1 Lot

3005 SOW Task 4.6 (FFP) – Option Period 3

Web Application Maintenance &

Enhancements

12 Month

3006 SOW Task 4.7 (FFP) – Option Period 3

Project Management Support

12 Month

3007 SOW Task 4.8 (Labor Hour) Opt Period 3

Web Development and Maintenance for the

Center for Tobacco Products

1 Lot

3008 SOW Task 4.9 (Labor Hour) Opt Period 3

Web Development and Maintenance for the

Office of Regulatory Affairs

1 Lot

4001 SOW Task 4.2 (FFP) – Option Period 4

Hosting Services

12 Month

4002 SOW Task 4.3 (FFP) – Option Period 4

Web Caching Services & Support

12 Month

4003 SOW Task 4.4 (Labor Hour) Opt Period 4

Search Services

1 Lot

4004 SOW Task 4.5 (Labor Hour) Opt Period 4

Web Content Management System

1 Lot

4005 SOW Task 4.6 (FFP) – Option Period 4

Web Application Maintenance &

Enhancements

12 Month

4006 SOW Task 4.7 (FFP) – Option Period 4

Project Management Support

12 Month

4007 SOW Task 4.8 (Labor Hour) Opt Period 4

Web Development and Maintenance for the

Center for Tobacco Products

1 Lot

4008 SOW Task 4.9 (Labor Hour) Opt Period 4

Web Development and Maintenance for the

Office of Regulatory Affairs

1 Lot

5001 IDIQ (NTE) – Length of Contract 1 Lot

6001 SOW Task 4.1 (Optional) (Labor Hour)

Contract Transition Activities

1 Lot

Net Amount

1. CONTRACT TYPE: Hybrid Firm-Fixed-Price(FFP) / Labor Hour / Indefinite-

Delivery/ Indefinite-Quantity (IDIQ) Contract – This is a hybrid contract utilizing Firm- Fixed-Price (FFP), Labor Hour and Indefinite-Delivery/Indefinite-Quantity (IDIQ) elements per FAR subparts 16.2, 16.5 and 16.6. The following tasks, throughout the life of this contract, shall be awarded using FFP contract line items: Hosting Services (4.2), Web Caching Services and Support (4.3), Web Application Maintenance and Enhancements (4.6), and Project Management Support (4.7). The following tasks, throughout the life of this contract, shall be awarded using Labor Hour contract line items: Contract Transition Activities (4.1), Search Services (4.4), Web Content Management System (4.5), Web Development and Maintenance for the Center for Tobacco Products (4.8) and Web Development and Maintenance for the Office of Regulatory Affairs (4.9).

The remaining requirement, Indefinite Delivery/Indefinite Quantity (4.10), shall be procured using IDIQ procedures per section 8. At the discretion of the Contracting Officer, the Government may use a variety of contract types under this contract, including, but not limited to: Firm-Fixed-Price (FFP), Time and Materials (T&M), 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 contract type.

2. MINIMUM AND MAXIMUM QUANTITIES

The contract’s guaranteed minimum is the firm-fixed-price tasks for the base period of the contract. The contract’s estimated maximum shall be the then current total estimated amount of the contract including the amounts of the base and all option periods, and the estimated IDIQ amount (contract line item 5001).

3. OVERVIEW OF PRICING SCHEDULES

3.1 The Contractor’s pricing schedules (reflected in the continuation of the SF 1449) for labor categories, travel and other direct costs (ODC) are incorporated from Attachment 2, Pricing Sheet. Attachment 4, Labor Categories, provides a detailed description of each category. The tables in Attachment 2 contain pricing per contract period for: each firm-fixed-price task included in the SOW; each labor hour task included in the SOW; hourly labor rates, per contract period, for both government site and contractor site performance for the IDIQ task in the SOW; travel costs per contract period; and ODC costs per contract period. The hourly rates for each labor category shall be fully burdened to include wages, fringe benefits, overhead, general and administrative expenses, and/or profit.

3.2 IDIQ CLIN 5001 shall contain all pricing for task 4.10 “Indefinite Delivery/Indefinite Quantity” for the following for the life of the contract:

a) Labor

b) Reimbursement of travel expenses

c) Reimbursement of Other Direct Costs

For further information on the reimbursement rules and regulations for both travel and ODCs, see sections 10 and 11 of this contract.

3.3 The pricing schedule shall:

a) serve as a list of the fixed price to be paid by the Government for any contract line item (CLIN) deemed firm-fixed-price;

b) serve as the ceiling price, or Not to Exceed (NTE) amount, for each CLIN deemed labor hour

c) serve as the ceiling price, or Not to Exceed (NTE) amount, for CLIN 5001 “IDIQ” for the life of the contract

3.4 Under firm-fixed-price, labor hour or IDIQ type tasks or task orders, the Government shall not pay a price for a CLIN in excess of the ceiling established in the Pricing Schedule.

4. PRICING TERMS

The unit prices specified in an IDIQ task order shall be derived from Attachment 2, Pricing Sheet, for the contract 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 IDIQ unit prices shall also 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 an IDIQ task order.

The unit prices specified in Labor Hour (LH) contract line items and task orders shall be fixed for the contract line item or 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 labor hour task order or contract line item.

For Firm Fixed Price (FFP) task orders and contract line items issued under this contract, the applicable unit price for the contract line item or task order shall be the total 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 or award is issued. The price(s) specified in FFP task orders and contract line items issued under this contract is/are fixed and not subject to adjustment.

5. MATERIAL HANDLING FEE

Reimbursement for material handling fee shall not be in excess of 5% on any subcontractor and material expenses on task orders issued under this contract.

6. PERIOD OF PERFORMANCE

6.1 Base Period: 12 Full Months

(beginning date of award, subject to funds availability) Option year one: 12 Full Months Option year two: 12 Full Months Option year three: 12 Full Months Option year four: 12 Full Months

6.2 Work Week - Work at the Government installation shall be performed by the contractor within the normal work week unless differing hours are specified on the individual task orders. Contractor shall be available on call via cell phone or Blackberry device between 8:00AM and 8:00PM on days the Food and Drug Administration offices are open.

6.3 During times of inclement weather the Contractor is not required to provide on-site service on days when the Federal Government is closed. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Task Orders). In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor will follow directives issued by responsible officials concerning reporting for work.

6.4 Following is a list of holidays observed by the Government:

Name of Holiday Time of Observance New Year’s Day 1 January Martin Luther King Jr. Day Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December

6.5 If any of the above holidays occur on a Saturday or a Sunday, then such holiday shall be observed by the Contractor in accordance with the practice as observed by the assigned Government employees at the using activity.

7. PLACE OF PERFORMANCE

The contractor will be required to have their own facility to perform the work. Some work will be performed at the Food and Drug Administration locations in the Washington DC area. The location of work performed will be determined by the COTR. It is anticipated that work under tasks 4.5, 4.8, and 4.10 will be performed at the FDA facility. For the remaining tasks the COTR will provide 24 hour notice when work will need to be performed at an FDA location.

8. ORDERING

8.1 Task Orders. Ordering services, for the IDIQ portion of 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 clause FAR 52.216-18 “Ordering” in this contract. The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

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

1. FDA will issue an RFTOP via email. The RFTOP will include a SOW, the period and place of performance, the anticipated order type (LH, T&M or FFP), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

2. RFTOPs shall only be issued by the FDA's Office of Acquisitions & Grants Services contracting staff.

3. Contractor has three days in which to submit any questions about the RFTOP.

4. Unless otherwise specified in the RFTOP, all proposals are due 10 calendar days after the issuance of the RFTOP.

5. The Contractor shall submit proposals via email. Each proposal shall include a description of the Contractor’s approach to the task, a schedule of deliverables, resumes of any key personnel proposed and a price build up. The price buildup should include the labor categories to be utilized, the number of hours in each labor category, extended pricing for each labor category and a bottom line price/ceiling. The proposal shall address all areas of the requirement 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.

6. FDA will evaluate the task order proposals for technical acceptability and price reasonableness. FDA will consider the following technical factors: technical approach;

whether the labor mix is appropriate; whether the level of effort is sufficient, and whether any key personnel proposed have the requisite experience.

Each Task Order issued shall contain the following information: Task Order Number, Task Order Date, Accounting/Appropriation data, SOW, Deliverables, Price/Ceiling, Period of Performance, Delivery Instructions, Special Terms/Conditions Unique to the Task Order.

9. FDA INVOICE REQUIREMENTS

9.1 THE CONTRACTOR SHALL SUBMIT ALL INVOICES TO ALL ADDRESSEES IN THE

MANNER SPECIFIED BELOW. ACCEPTABLE METHODS OF DELIVERY INCLUDE MAIL AND

HAND DELIVERY. ELECTRONIC INVOICES ARE NOT ACCEPTED

9.1a ONE ORIGINAL AND ONE COPY TO THE APPROVING OFFICIAL (If different from below, address will be indicated on individual task orders):

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS & GRANTS SERVICES

ATTN: CONTRACTING OFFICER

5630 FISHERS LANE

ROOM TBD, HFA-500

ROCKVILLE, MARYLAND 20857

9.1b ONE COPY TO THE CONTRACTING OFFICER TECHNICAL REPRESENTATIVE (COTR) OR

OTHER PROGRAM CENTER/OFFICE DESIGNEE:

[To be specified prior at award]

INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS

SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY

ELECTRONIC FUNDS TRANSFER – CENTRAL CONTRACTOR REGISTRATION) AND/OR

OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN. TO CONSTITUTE A PROPER

INVOICE, THE INVOICE MUST BE SUBMITTED ON COMPANY LETTERHEAD AND INCLUDE

EACH OF THE FOLLOWING:

(I) NAME AND ADDRESS OF THE CONTRACTOR;

(II) INVOICE DATE AND INVOICE NUMBER;

(III) IDIQ CONTRACT/TASK ORDER NUMBER;

(IV) DESCRIPTION, QUANTITY, UNIT OF MEASURE, UNIT PRICE, AND

EXTENDED PRICE SUPPLIES DELIVERED OR SERVICES PERFORMED, INCLUDING:

(a) PERIOD OF PERFORMANCE FOR WHICH COSTS ARE CLAIMED;

(b) ITEMIZED TRAVEL COSTS, INCLUDING ORIGIN AND DESTINATION;

(c) ANY OTHER SUPPORTING INFORMATION NECESSARY TO CLARIFY

QUESTIONABLE EXPENDITURES;

(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 PURCHASE ORDER/AWARD, 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, INCLUDING

ROUTING TRANSIT NUMBEROF THE FINANCIAL INSTITUTION RECEIVING

PAYMENT AND THE NUMBER OF THE ACCOUNT INTO WHICH FUNDS ARE TO BE

DEPOSITED;

(XI) NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER

TECHNICAL REPRESENTATIVE (COTR) OR OTHER PROGRAM CENTER/OFFICE POINT

OF CONTACT, AS REFERENCED ON THE CONTRACT;

(XII) ANY OTHER INFORMATION OR DOCUMENTATION REQUIRED BY THE

CONTRACT/AWARD.

C. QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA

PAYMENT OFFICE AT:

FDA/OC/OA/OFO/OFS

ATTN: DIVISION OF PAYMENT SERVICES

12345 PARKLAWN DRIVE, HFA-720

301.827.3742 OR 866.807.3742

fdavendorpaymentsteam@fda.gov

ROCKVILLE, MARYLAND 20857

9.2 Invoices shall be broken down by Contract Line Item Numbers (CLINs) performed during the period of performance. Fixed price tasks shall be separate from labor hour tasks. Labor hour tasks shall be further broken out by individual tasks, labor categories, personnel name, total hours, and rates. Labor hour tasks shall include current and cumulative charges for the period of performance.

9.3 Twelve monthly contract burn rate reports per year in spreadsheet format delivered to the CO and COTR when invoices are submitted for payment. Tracking spending by task in columns and an entry for each invoice. Displaying contract period totals and funding with remaining balance.

mailto:fdavendorpaymentsteam@fda.gov

9.4 For tasks performed under IDIQ CLIN 5001, the individual task order shall declare the invoicing requirements for that award, if different from the requirements in this section.

9.5 With each invoice, the Contractor shall submit to the CO a cumulative report demonstrating compliance with FAR Clause 52.219-14, Limitation on Subcontracting. If not in compliance, the report shall include the corrective actions taken or planned to be in compliance.

10. TRAVEL

10.1 Travel expenses will be included in monthly invoices, and will require pre-approval from the COTR. The contractor shall provide an expense report outlining all expenses that will need to be reimbursed. This attachment shall be included in the monthly invoice.

10.2 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 contract may require travel by contractor personnel. If travel, domestic or overseas, 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

• Passports,

• visas, etc.

• Security Clearances

(b) Travel Policy - (1) The costs for travel, subsistence, and lodging shall be reimbursed to the contractor only to the extent that it is necessary and authorized for performance of the work under this contract. The costs for travel, subsistence, and lodging shall be reimbursed to the contractor in accordance with the Federal Acquisition Regulation (FAR) 31.205-46.

Reimbursement for the costs incurred for lodging, meals and incidental expenses (as defined in the travel regulations cited subparagraphs (b)(i) through (b)(iii) below) shall be considered to be reasonable and allowable only to the extent that they do not exceed on a daily basis the maximum per diem rates in effect at the time of travel as set forth in the following:

(i) Federal Travel Regulation prescribed by the General Services Administration for travel in the contiguous 48 United States;

(ii) Standardized Regulations, (Government Civilians, Foreign Areas), Section 925, “Maximum Travel Per Diem Allowances in Foreign Areas” prescribed by the Department of State, for travel in areas not covered in the travel regulations cited in subparagraphs (b)(1)(i) and (b)(1)(ii) above.

(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

(1) The contractor shall not be paid per diem for contractor personnel who reside in the metropolitan area in which the tasks are being performed. Per diem shall not be paid on services performed at contractor’s home facility and at any facility required by the contract, or at any location within a radius of 50 miles from the contractor’s home facility and any facility required by this contract.

(2) Costs for subsistence and lodging shall be paid to the contractor only to the extent that overnight stay is necessary and authorized in writing by the Government for performance of the work under this contract. When authorized, per diem shall be paid by the contractor to his employees at a rate not to exceed the rate specified in the travel regulations cited in FAR 31.205-46(a)(2) and authorized in writing by the Government.

The authorized per diem rate shall be the same as the prevailing locality per diem rate.

Written Government authorization will be by written notice of approval from the Contracting Officer’s Technical Representative (COTR).

(3) Reimbursement to the contractor for per diem shall be limited to payments to employees for authorized per diem, as described above, not to exceed the authorized per diem. Fractional parts of a day shall be payable on a prorated basis for purposes of billing for per diem charges attributed to subsistence on days of travel. Fractional billing shall be on a 1/4, 1/2, and 3/4 basis. The contractor shall retain supporting documentation for per diem paid to employees as evidence of actual payments.

(e) Transportation

(1) 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 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.

(2) 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.

(3) 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.

11. OTHER DIRECT COSTS (ODC)

11.1 Any Other Direct Costs (ODC) should be submitted through the invoice. All ODC, other than those ODC acquired under the firm-fixed-price line items, must be pre-approved by the Contracting Officer.

11.2 To be eligible to receive reimbursement for ODC the Contractor must obtain at least three quotes for each transaction in excess of $2,500 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 need provide the aforementioned documentation only when requested by the Contracting Officer.

11.3 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.

(i) A description of the ODC.

(ii) Identification of the proposed subcontractor and price.

(iii) Suppliers contacted and price quotes. Include other pertinent data such as price lists used if suppliers were not contacted and information regarding the selection if other than price-related factors were considered.

11.4 The Contracting Officer may reduce the reimbursement by any amount above that which the Contracting Officer finds, 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.

12. GOVERNMENT FURNISHED EQUIPMENT/GOVERNMENT FURNISHED

INFORMATION

12.1 Government Furnished Equipment (GFE) includes a networked PC (laptop) installed with the FDA standard software for all contract personnel performing work on the FDA network or hosted environment. Personnel responsible for 24 hour responsibility will be furnished with an FDA Blackberry. Government space will be provided for up to 12 contractor personnel. But, depending on the nature of the work, the FDA business owner may provide additional space. The Government provided space is composed of 10 individual cubicles, and desks in a shared space common area. 4 telephones will be provided for shared use amongst the 12 spaces.

12.2 Government Furnished Information (GFI) includes Standard Operating Procedures, enterprise architecture standards, and other supplemental documentation to be provided to offeror upon award.

13. CONTRACTING OFFICER AND AUTHORIZED CHANGES ONLY BY

CONTRACTING OFFICER

13.1 Except as specified in paragraph 14.2 below, no order, statement, or conduct of Government personnel who visit the Contractor’s facilities or in any other manner communicates with Contractor personnel during the performance of this contract shall constitute a change under the Changes clause of this contract.

13.2 The Contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

13.3 The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof. The address and telephone number of the Contracting Officer is:

Name: TBD Address:

Phone Number:

E-mail:

14. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)

14.1 The Contracting Officer herby appoints the following individual(s) as Contracting Officer’s Technical Representative(s) (COTR) for this contract/order:

Name: TBD Address:

Phone Number:

E-mail:

14.2 It is emphasized that only the Contracting Officer has the authority to modify the terms of the contract, therefore, in no event will any understanding agreement, modification, change order, or other matter deviating from the terms of the basic contract between the Contractor and any other person be effective or binding on the Government. When/If, in the opinion of the Contractor, an effort outside the existing scope of the contract is requested, the Contractor shall promptly notify the Contracting Officer in writing. No action shall be taken by the Contractor unless the Contracting Officer approves in writing and/or issues a contract modification.

14.3 Technical Direction. Performance of the work under this contract shall be subject to the technical direction of the COTR. 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 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 FAR 52.212-4 “Contract

Terms and Conditions – Commercial Items.”

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

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

15. INFORMATION SECURITY

Information Security is applicable to this solicitation and the following is provided to assist in proposal preparation.

15.1 IMPORTANT NOTE TO OFFERORS: The following information shall be addressed in a separate section of the Technical Proposal entitled, "INFORMATION SECURITY."The Federal Information Security Management Act of 2002 (P.L. 107-347) (FISMA) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including subcontractor), or other source. The National Institute of Standards and Technology (NIST) has issued a number of publications that provide guidance in the establishment of minimum security controls for management, operational and technical safeguards needed to protect the confidentiality, integrity and availability of a Federal information system and its information.

15.2 The Statement of Work (SOW) requires the successful offeror 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 following requirements apply to this solicitation:

15.2.1 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] Mission Based Information:

(b) Security Categories and Levels Confidentiality Level: [ ] Low [X] Moderate [ ] High Integrity Level: [ ] Low [ ] Moderate [X] High Availability Level: [ ] Low [ ] Moderate [X] High Overall Level: [ ] Low [X] Moderate [ ] High

Position Sensitivity Designations - Prior to award, the Government will determine the position sensitivity designation for each contractor (including subcontractor) employee that the successful offeror proposes for work under the contract. For proposal preparation purposes, the following designations apply:

[x] Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC). 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).

15.3 Upon award, the contractor will be required to submit a roster of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a federal information system(s). The Government will determine and notify the Contractor of the appropriate level of suitability investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

http://ais.nci.nih.gov/forms/Suitability-roster.xls

15.4 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.

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

15.6 Information Security Training - HHS policy requires contractors/subcontractors receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements.

15.7 The successful offeror will be responsible for assuring that each contractor/subcontractor employee has completed the NIH Computer Security Awareness Training course at:

http://irtsectraining.nih.gov/ prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract. The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COTR.

15.8 Additional security training requirements commensurate with the position may be required as defined in NIST Special Publication 800-16, Information Technology Security Training Requirements (http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf).

This document provides information about information security training that may be useful to potential offerors.

16. PERSONNEL SECURITY CLEARANCE REQUIREMENTS

16.1 BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

16.2 GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this order:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

http://irtsectraining.nih.gov/ http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf)

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the order.

The position risk levels for this order are Level 5

There are two (2) potential position risk levels, which are:

Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the order will provide the name of the appropriate Personnel Security Specialist to the Contractor. A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

16.3 BADGING PROCESS

The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work.

Fingerprints will be submitted in one of two ways, depending on where the order will be performed:

Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

Contractor employees who will work in a field office will submit fingerprints to:

Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM 1201 Silver Spring, MD 20993 Phone: (301) 796-4592

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

16.4 BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 5 and 6 serving under this order.

Required background investigations may include, but not be limited to:

Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;

Searches of credit bureaus;

Personal interviews; and Written inquiries covering the subject's background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of order performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the order number, the name of the Contracting Officer administering the order, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

10903 New Hampshire Ave, RM 1201 Silver Spring, MD 20993 Phone: (301) 796-4592

The contractor shall send a separate letter to the Contracting Officer that includes the order number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff will resolve with the order employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the order, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the order. Those who are not cleared must cease work on the order immediately.

If a Contractor employee changes job responsibilities under this order, the contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Project Officer.

16.5 PERSONNEL SECURITY CHARTS

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE

POSITIONS - LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN REQUIRED SUBMIT

TO

DATE

REQUIRED

FDA Form 3391 - FDA Security Card Access Request

COTR.

Sponsorship must be provided by

FDA COTR.

All positions on DHHS property or leased space

Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement

Contracting Officer

All positions with access to non-public privileged, proprietary, Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of form or trade secret information work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release

Contractor generated

All positions, including intermittent, per diem or temporary

* Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM Silver Spring, MD 20993

Ten (10) calendar days prior to commencement of work

SF 85 - Questionnaire for Non-Sensitive Positions

Online via OPM’s e-QIP system

Non-Sensitive Positions

- Level 1 Clearance

*Submit to OPM online via the e- QIP system

Ten (10) calendar days upon request of the Contracting Officer

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting Officer

Non-Sensitive Positions

- Level 1 Clearance

* Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM Silver Spring, MD 20993

Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes:

contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer *Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

Food and Drug Administration OSO/Office of Security Operations

Attn: Personnel Security Staff 10903 New Hampshire Ave, RM 1201

Phone: (301) 796-4592

CHART B

Public Trust Positions - Levels 5 or 6

FORM NAME

OBTAIN

FROM

WHEN REQUIRED SUBMIT

TO

DATE

REQUIRED

SF 85P - Questionnaire for Public Trust Positions

Online via OPM’s e-QIP system

Public Trust Positions - Level 5 or 6 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting Officer

Public Trust Positions - Level 5 or 6 Clearance

* Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM 1201 Silver Spring, MD 20993

Ten (10) calendar days prior to commencement of work

FDA Form 3391 - FDA Security Card Access Request

COTR.

Sponsorship must be provided by

FDA COTR.

All positions on DHHS property or leased space

Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, RM 1201 Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement form

Contracting Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of

Contractor generated

All positions, including intermittent, per diem or temporary

* Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff

Ten (10) calendar days prior to commencement birth, former names, and a completed Fair Credit Reporting Act Release

10903 New Hampshire Ave, RM 1201 of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes:

contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

16.6 FDA 3398 – ACCESS TO NON-PUBLIC INFORMATION

All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement form provided as Attachment 10 to this order. If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this order, the contractor shall notify the FDA Project Officer (P.O.) and Contracting Officer.

Any new contractor and subcontractor employees assigned to this order shall sign the form, and the contractor shall hand-deliver it (ten (10) days prior to commencement of work) to the Contracting Officer.

The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted.

16.7 Briefings

A FDA representative (typically, the Project Officer) will conduct an orientation briefing for the contractor/contractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/ADP requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The contractor shall brief all contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the order and of the responsibility to protect it.

The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized source. The contractor shall conduct an updated briefing annually and shall submit a report to the FDA Project Officer within ten (10) days after the briefing which includes: an outline of the briefing, a copy of any briefing materials, date briefing was conducted and the names of the attendees.

If this is an automated data processing/telecommunications (ADP/TC) order, in addition to the above briefings, the FDA Project Officer and the FDA Center/Office Information Systems Security Officer (ISSO) will…