Solicitation.pdf

RFP: FDA‐Off‐Site‐RIM‐000141

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Table of Contents

I. Pricing Schedule 4 II. Contract Administration Details 5 III. Special Contract Requirements 16 IV. Contract Clauses 36 V. Attachments and Appendices 47 VI. Solicitation Provisions 48

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SF1449 – Continuation Sheet

I. Pricing Schedule (See Attachment 5 – Pricing Spreadsheet)

1. Brief Description of Supplies or Services The U.S. Food and Drug Administration (FDA) is establishing an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide an off‐site fully integrated records facility (FIRF).

2. Contract Type: Indefinite Delivery/Indefinite Quantity (IDIQ) Contract This is an Indefinite Delivery/Indefinite Quantity (IDIQ) contract per FAR subpart 16.5. All tasks shall be procured using IDIQ procedures per section 20.

At the discretion of the Contracting Officer, the Government may use a variety of contract types when issuing task orders under this contract, including: 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.

3. Minimum and Maximum Quantities The concurrent award of the base period of the initial task order fulfills the minimum order guarantee.

The maximum aggregate dollar value of task orders awarded over the 5 year IDIQ ordering period cannot exceed the established contract ceiling of $103,000,000.00.

4. Pricing Terms The agreed upon negotiated Labor Rates, derived from Attachment 5, IDIQ Pricing Sheet, shall be fixed for the duration of this contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. Labor Rates proposed for Task Orders issued against this IDIQ contract must be in accordance with agreed upon IDIQ Labor Categories and Fixed Labor Rates. If a task order is extended, as a result of a direct action or inaction by the Government, which delays the Contractor from completing the task order within the Period of Performance identified, the Contractor may use the Labor Rates associated with the contract year in which the extension crosses. However, in no event shall the Contractor perform, or be paid for any work which exceeds the not‐to‐exceed dollar amount of a task order. The IDIQ Pricing Sheet will be incorporated into the contract after award.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort, fixed labor rate for labor mix proposed, allowable other direct costs and indirect cost, and timeframe in which the services are estimated to be performed. The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued. The FFP specified in the FFP task orders issued under this contract is/are fixed and not subject to adjustment.

Each Labor‐Hour or Time‐and‐Materials task order will contain a ceiling price. The Contractor shall comply with FAR 52.232‐7 Payments under Time‐and‐Materials and Labor‐Hour Contracts (Aug 2012), in regards to the ceiling price for the individual task order(s)(ITO).

5. Discounts

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The contractor is encouraged to offer any and all discounts for goods and services provided under future task orders. The type or amount of discount may vary based on the circumstances of each particular task order and should be proposed in accordance with the Contractor’s pricing policies.

6. Material Handling Fee Reimbursement for a material handling fee shall not be in excess of (TBD)% on any subcontractor and material expenses on time and materials task orders under this contract.

II. Contract Administration Details

7. Period of Performance

The ordering period is for a total of 60 months, consisting of five (5) twelve (12) month rate periods.

Year 1 Ordering Period rates: 12 months Year 2 Optional Ordering Period Rates: 12 months Year 3 Optional Ordering Period Rates: 12 months Year 4 Optional Ordering Period Rates: 12 months Year 5 Optional Ordering Period Rates: 12 months

8. Place of Performance The contractor will be required to work at the Contractor site and provide courier services to multiple FDA facilities each weekday.

Specific working arrangements such as telework will be outlined in ITOs. FDA facilities operate predominantly in the Washington, DC Metropolitan area with concentrations in the FDA's Maryland locations of Bethesda, College Park, Laurel, Rockville, and Silver Spring.

9. Observance of Legal Holidays & Other Government Closings Coverage is expected during all Federal work days. Services will not be performed at the Federal site when the Federal Government is closed for reasons such as inclement weather or executive order. No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below unless specifically requested by the COR (in the best interest of industry coverage).

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management (OPM) or other such official for late arrivals or early departures due to inclement weather

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(unless otherwise specified in the ITOs). In the event Federal Government employees are granted unscheduled telework, the Contractor is required to provide services.

In the event the Federal Government is closed by order of the President of the United States or the OPM 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 COR and/or CO concerning reporting for courier services. In the absence of any OPM announcement, the presumption is that Federal Agencies are open and operating under normal circumstances.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO shall notify the Contractor of Facility closings, and specify the time for a final document pickup.

10. Hours of Operation The Contractor staff shall be available during normal FDA business hours from 8:00 am – 5:00 pm EST, Monday through Friday except on Legal Holidays (refer to section 9).

The Contractor may be required to deliver documents and records materials after hours. After hours is defined as after normal business hours Monday through Friday, weekends, and holidays. During after hours, the Contractor shall have the flexibility to use management tools (i.e. swing shifts) to successfully meet ITO requirements. Any overtime incurred must be approved in advance, in accordance with 52.232‐ 7 Payments under Time and Materials and Labor Hour Contracts (Aug 2012).

11. Deliverables

Deliverables will be specified in the task orders issued under this contract. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures according to FAR 52.212‐4(a) Inspection/Acceptance.

12. Contract Management

Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contract/ITO will require maximum coordination between the Government and the Contractor.

Communications pertaining to the contract administration will be addressed to the Contracting Officer.

No changes to the statement of work are authorized without a written modification to the contract/ITO executed by the Contracting Officer.

The Contractor is advised that only the Contracting Officer can change or modify the contract/ITO terms or take any other action, which obligates the Government. Then, such action must be set forth in a formal written modification to the contract/ito.

Contractors who reply on direction from other than the Contracting Officer do so at their own risk and expense. Such actions do not bind the Government contractually. Any contractual questions shall be directed to the Contracting Officer or Contract Specialist.

13. Government Points of Contact

13.1 Address and phone number of the Contracting Staff:

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Contract Specialist: Contracting Officer (Alt POC):

Tania Gates Jennifer Fagan 5630 Fishers Lane, Room 2116 5630 Fishers Lane, Room 2074 Rockville, MD 20857 Rockville, MD 20857 Phone: 240.402.7580 Phone: 240.402.7576 Email: Tania.Gates@fda.hhs.gov Email: Jennifer.Fagan@fda.hhs.gov

13.2 IDIQ Contracting Officer’s Representative (COR)

The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative) to act as her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract.

The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this contract.

The following person has been appointed as the IDIQ Contracting Officer Representative:

Contracting Officer Representative (COR): TBD

13.3 Task Order COR

For each Task Order, a COR will be assigned. The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction in accordance with section 16; and, (7) reviewing of invoices/vouchers.

The Government may unilaterally change its COR designation at any time without prior notice to the Contractor.

13.4 Task Order Project Managers

Task Order project managers may assist the COR. The project managers will not have the authority to provide technical direction in accordance with section 16; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances as required by this performance; and (5) reviewing of invoices/vouchers.

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14. Contractor’s Contract Administration Information

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

Name and Title:

Responsible Office:

Address:

Telephone Number:

Fax Number:

E‐mail Address:

15. Contractor Key Personnel In accordance with HHSAR 352.242‐70:

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.

The individual cited below is key personnel:

IDIQ Level Program Manager

As tasked, each ITO will identify the Contractor key personnel necessary.

16. Technical Direction Performance of the work under task order shall be subject to the technical direction of the Task Order COR. The term “technical direction” is defined to include, but is not limited to, 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 descriptions.

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 COR 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.

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Constitutes a change as defined in the applicable contract clause entitled FAR 52.212‐4(c) Contract Terms and Conditions – Commercial Items.

In any manner cause an increase or decrease in the total estimated contract cost or the time required for contract performance.

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

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

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the categories described above, the Contractor shall not proceed but shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer to modify the task order, accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract.

The Contractor shall proceed immediately with the instructions or directions and shall be subject to the “Disputes” clause within FAR 52.212‐4(d) “Contract Terms and Conditions – Commercial Items”.

17. 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 the timely performance by the Contractor or affect the contract costs or funding, the Contractor is required to immediately notify the Contracting Officer identified in section 13.1.

18. Invoice Procedures

18.1 Specific invoicing instructions will be specified in each task order.

General instructions require the contractor shall submit all invoices to all addresses in the manner detailed below.

Acceptable methods of delivery include mail, electronic and hand delivery.

1. One copy to the Contract Specialist (as specified in each individual task order). If submitted electronically, contract number/task order number shall be referenced in the subject line.

2. One PDF version to the COR – clearly marked “Courtesy Copy Only” to the COR (as specified in each individual task order).

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 – System for Award Management) and or other applicable FAR clauses contained in this contract, and must contain the following:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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(iii) Contract number, task order number and line item numbers;

(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;

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

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

(xi)DUNS number.

An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items, listed in

(i) through (xi) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead, must contain no ink changes and be legible for printing.

Direct questions regarding payment to the FDA Payment Office at:

FDA/OC/OA/OFO/OFS

ATTN: DIVISION OF PAYMENT SERVICES

10903 New Hampshire Ave White Oak Bldg 32, Mail Hub 2145

301.827.3742 OR 866.807.3742

OFS/PaymentServices@fda.hhs.gov Silver Spring, MD 20993‐0002

18.2 If applicable, invoices must include a list of tasks performed during the period of performance, broken down by labor categories, and personnel name. Total hour per labor category and rates must be broken out and clearly defined for each task and personnel per invoice.

18.3 With each invoice, the Contractor shall submit to the Contracting Officer a cumulative report, for the entire contract, 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.

18.4 The Contractor shall be registered in SAM and ensure that the SAM record is updated annually.

19. Ordering

19.1 Task Orders – Ordering services 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 provisions of clause FAR 52.216‐18 “Ordering” in this contract. The only office authorized to process task orders through the Food and Drug Administration (FDA) is the Office of Acquisitions & Grants Services Contracting Officer (CO) for any of the Centers within the FDA.

Each ITO will reference performance requirements for data volume and timelines which may also include required reporting processes and/or document handling procedures. Additionally, the

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FDA may stipulate salient characteristic requirements for contractor‐provided equipment coupled with mandatory IT security software installation.

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

1. FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue a RFTOP via email.

The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (FFP, T&M or LH), reporting requirements and deliverables, key personnel and any special terms and conditions applicable to the Task Order.

2. Within ten (10) business days (unless another time frame is specified in writing) the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling.

3. FDA will evaluate the task order proposal for technical acceptability and price reasonableness.

FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. The Contractor shall voluntarily have the opportunity to create value engineering efficiencies. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

4. Once the proposal is acceptable, the Contracting Office will issue the task order.

5. Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. SOW

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order.

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer is undertaken at risk.

19.3 Emergency Orders ‐ In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the Contracting Officer may verbally authorize performance to commence immediately so long as the work to be performed in the emergency situation is within the scope of this contract. In those instances, a written work plan shall be submitted with 10 calendar days following the authorization to commence work. When work is authorized to commence prior to the submission and negotiation of a work plan, the

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Contracting Officer will indicate at time of authorizing work a dollar ceiling that may not be exceeded except at the Contractor's own risk.

20. Travel

It is not anticipated that travel costs will be incurred by the Contractor during the life of this IDIQ vehicle as most work will be conducted at the contractor’s facility. If travel expenses are deemed necessary in ITO’s the costs shall be pre‐negotiated and cited in ITO’s. Costs shall be in accordance with the Federal Travel Regulations and the Contractor will be reimbursed based on number of trips, number of persons traveling, lodging, per diem, and air / rail / car transportation.

Federal Travel Regulations can be accessed at:

http://www.gsa.gov/portal/content/104790?utm_source=OGP&utm_medium=print‐ radio&utm_term=federaltravelregulation&utm_campaign=shortcuts

21. Other Direct Costs (ODC)

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

21.2 To be eligible to receive reimbursement for ODC the Contractor must obtain at least three quotes for each transaction in excess of $3,000.00 to ensure that adequate price competition was sought or the Contractor must provide an acceptable justification as to why it was impracticable to do so.

For purchases of ODC, the Contractor needs to provide the aforementioned documentation only when requested by the Contracting Officer.

21.3 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.

21.4 The Contractor is authorized to utilize the General Services Administration (GSA) Federal Supply Schedules to acquire items needed for the performance of this contract.

22. Post Award Administration

With the establishment of performance‐based contracting, it is necessary to establish a deduction in costs for those deliverables which are not met in a timely fashion or do not meet the quality level expected. If a deliverable is found by the FDA COR to be sub‐standard, it may require alterations be made until the deliverable meets the standard expectations at which point it is considered delivered. In some ITO’s the deliverable must be 100% by the delivery date. The delivery date will be determined by the ITO. The Quality Assurance Surveillance Plan (QASP) will be developed in the planning stage of each offeror’s proposal. The Contractor shall voluntarily have the opportunity to create value engineering efficiencies.

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23. Government Furnished Equipment/Government Furnished Information

23.1 GENERAL

Each task order will identify Government Furnished Equipment (GFE) and Government Furnished Information (GFI).

FDA reserves the right to provide laptops, tower computers, printers, scanners, copier, data cable line, and basic PC desktop images and Center Software Top‐Offs for FIRF. Upon receipt of FDA badges, FDA will provide Contractor FDA network access to staff under this contract. FDA will provide access to any server‐based environment necessary to accomplish the stated work.

Government Furnished Information will be accessible through the FDA network and paper copies, as needed. The contractor shall inform and require staff to comply with Government regulations that prohibit the use of any Government property for personal use.

FDA shall retain all rights and privileges, including those of patent and copy, to all Government‐ furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data. These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

The FDA Master Approved Technology (MAT) list contains a list of software applications and equipment approved by the Office of Information Management (OIM). The approved technologies are determined to be compatible with FDA’s Technical environment. The MAT list is posted on FDA’s intranet at http://apex.test.fda.gov/pls/apex/f?p=130:1:3075983010524334 (available after contract award).

All Contractor peripheral equipment connected to FDA computers or laptops must be on the MAT List. If Contractor equipment and software is not on the MAT List, it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

The MAT list will be available to authorized Contractor employees after contract award. In addition, FDA posts a list of technologies not approved by OIM on the intranet.

FDA has instituted the Information Technology Information Management (ITIM) approval process in order to track technologies across the Agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor may be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion. FDA Center IT Investment Review Boards may need to be included in a coordinated review process.

23.2 Relocation of Equipment

The Contractor shall work with the FDA Help Desk Support to relocate/install all GFE to ensure no breaks in current work performance.

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23.3 Equipment Maintenance

The Government will provide and maintain any government‐issued computer equipment provided to the Contractor and any other equipment specified in ITOs. The Contractor shall immediately notify the Government in writing when maintenance or repair is needed, unless such repair is necessary due to any fault by the Contractor (refer to Section 25).

23.4 Equipment Supplies

The contractor shall be responsible for providing any supplies necessary to operate the GFE (other than maintenance/repair supplies)

23.5 FDA Information Technology (IT) Help Desk Support

Help Desk Support will be provided by the FDA for only FDA functions inclusive of support for all Government Furnished Property (GFP) and software. FDA’s Help Desk is responsible for distributing new and replacement laptops as they are needed and configuring laptops with standard and Center specific software. FDA Help Desk Support will be provided through remote access, drop‐in support, or when the Contractor transports the equipment to the nearest FDA IT servicing location. Drop‐in support services include: transition‐in services and support for major technology changes that cannot efficiently be accomplished remotely. Upon request by FDA Help Desk Support, the Contractor shall be responsible for transporting the items in need of repair to and from the designated FDA facility for repair. In addition the FDA’s Help Desk provides best effort support – defined as basic troubleshooting ‐ for peripheral equipment connected to FDA owned computers. FDA does not grant the Contractor administrative rights for Government‐ owned computers. If required, the Contractor shall submit a request for administrative rights using the Form 3530 and submit to FDA for approval.

23.6 Protection of Federal Government Property and Buildings

The Contractor assumes full responsibility for any and all loss or damage of any nature to any and all Federal Government property that is caused by an act or failure to act on behalf of the Contractor and the Contractor shall indemnify the Federal Government for such loss or damage.

Contractor liability extends to the unauthorized retention, dissemination, and/or sharing of confidential material or information that the Contractor may gain access to in the performance of the services required under this contract.

In addition to the applicable "Government Property" the Contractor shall comply with the provisions of DHHS publication "Contractor's Guide for Control of Government Property," which is hereby incorporated by reference. The guide is available on the HHS website:

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

pdf

All references in the Guide to the acquisition cost threshold for accountable property are changed to $5,000. Additionally all references to HHS 565 in the Guide are deleted. The form is obsolete.

The Contractor shall inventory all accountable Government property and submit a list of that property to the CO on commencement of the contract, usually concurrent with transfer of the

15 | P a g e property, annually on the anniversary of contract award, and within ninety (90) days after completion or termination of the contract.

The inventory list, reflecting each item of accountable property as a separate line item, should contain the following data elements:

1. Barcode/tag number

2. Item name/description

3. Manufacturer's name

4. Manufacturer's model number

5. Manufacturer's serial number

6. Unit cost

7. Date received/inventoried

8. Contract number

9. Remarks (optional)

23.7 Mitigation of Furniture, Material and Equipment Damages

If, due to any fault of the Contractor, its employees, agents, or sub‐contractors, Government owned property is lost or damaged during the performance of this contract, the Contractor shall be responsible to FDA for such loss or damage. The Contractor’s liability, at a minimum, shall be measured by the repair or replacement cost, whichever is less. The Contractor shall reimburse FDA within thirty (30) calendar days after the submittal of any such claim.

23.8 Report on Access to Government Property

The Contractor shall ensure that all Contractor employees are informed that they are not to use any Government property for personal use. To ensure that the employees are informed of this policy, the Contractor shall submit to the CO two (2) copies of a Yearly Report on Access to Government Property, documenting and summarizing the Contractor's program for the protection, preservation and maintenance of all Government property, procedures to educate their employees concerning individual responsibilities for Government property, and efforts to monitor and assess the Contractor's property control system.

24. Contractor Provided Equipment

Unless otherwise noted, the Contractor shall provide all equipment and materials for performance of each task order. The Contractor shall supply vehicles for use in pick‐up and delivery of documents (applications and submissions) and mail or other items as specified in each task order. The Contractor is authorized to utilize the General Services Administration (GSA) Federal Supply Schedules to acquire items needed for the performance of this contract.

25. Reporting Matters Involving Fraud, Waste and Abuse

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Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA‐ funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1‐800‐HHS‐TIPS (1‐800‐447‐8477). All telephone calls will be handled confidentially. The e‐mail address is Htips@os.dhhs.gov and the mailing address is: Office of Inspector General Department of Health and Human Services TIPS HOTLINE P.O. Box 23489 Washington, D.C. 20002.

III. Special Contract Requirements

26. Personnel Security Requirements

26.1 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.

Contractor employees who will be accessing the FDA network shall adhere to the background investigation requirement, as they will require badges to access the system.

26.2 GENERAL

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

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" (Attachment 8) forms signed by each employee named in paragraph a. above.

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 gain access to DHHS‐owned or leased property without an escort and access to GFE PCS and/or laptops). (See Section 26.3 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.

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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 contract.

The position risk levels for this contract are 5. Each task order shall specify position risk levels for key personnel.

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

a. 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.

b. 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 COR for the contract 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.

26.3 BADGING PROCESS

The FDA COR 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 contract will be performed:

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

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

Food and Drug Administration Personnel Security Staff, OSO

10903 New Hampshire Ave Bldg 1, Room 1201 Silver Spring, MD 20993

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.

26.4 BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

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 contract 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 contract number, task order number, the name of the Contracting Officer administering the contract, 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:

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Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 10903 New Hampshire Ave, Bldg 1, Room 1201 Silver Spring, MD 20993

The contractor shall send a separate letter to the Contracting Officer that includes the contract 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 contract 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 contract, 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 contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, 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 COR.

26.5 NON‐PUBLIC DATA PROTECTION

The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

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*** The remainder of this page is intentionally left blank***

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

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

COR. Sponsorship must be provided by FDA COR.

All positions on DHHS property or leased space

Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 1201 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 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 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

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 5600 Fishers Lane

PKLN 15A‐22, HFA‐640

Rockville, MD 20857

(301) 827‐5502, ‐5521, ‐5507, ‐5508

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) 796‐4601

Contracting Officer Non‐Sensitive Positions ‐ Level 1 Clearance

*Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 1201

(301) 796‐4601, ‐4596, ‐4595

Ten (10) calendar days prior to commencement of work

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*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.

Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 1201 Silver Spring, MD 20993

Hours 8:00 a.m. ‐11: a.m. and 1:00 p.m.‐3:00 p.m. Mon‐Fri (301) 796‐4607 No appointment necessary

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) 796‐4601

Contracting Officer

Public Trust Positions ‐ Level 5 or 6 Clearance

*Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 1201 Silver Spring, MD 20993

(301) 796‐4601, 4595

Ten (10) calendar days prior to commencement of work

FDA Form 3391 ‐ FDA Security Card Access Request

COR.

Sponsorship must be provided by

FDA COR.

All positions on DHHS property or leased space

Food and Drug Administration

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 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 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

OC/OCM/OSOPP

Office of Security Operations, Policy & Planning

Attn: Personnel Security Branch 5600 Fishers Lane

Ten (10) calendar days prior to commencement of work

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PKLN 15A‐22, HFA‐640

Rockville, MD 20857

(301) 827‐5502, ‐5521, ‐5507, ‐5508

*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.

Personnel Security Branch 10903 New Hampshire Ave

Bldg 1, Room 1201 Silver Spring, MD 20993

Hours 8:00 a.m. ‐11:00 a. m. and 1:00 p.m. ‐3:00 p.m. Mon‐Fri.

No appointment necessary, (301)796‐4607

27. Access to Non‐Public Information

27.1 All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non‐Public Information Agreement form provided as an attachment to this contract (Attachment 8). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the contractor shall notify the FDA COR and Contracting Officer. Any new contractor and subcontractor employees assigned to this contract 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.

27.2 Briefings

A FDA representative (typically, the COR) 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 contract 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 COR 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) contract, in addition…