14-223-SOL-00003vFinal_Revised.pdf

14‐223‐SOL‐00003 Page 3 of 46 Food Applications Regulatory Management (FARM) System

SF1449 – Continuation Sheet

I. PRICING SCHEDULE (See Attachment 3 – Pricing Spreadsheet)

1. Brief Description of Supplies or Services The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), is one of six product‐oriented centers at the FDA that are charged with advancing a portion of the agency’s mission. CFSAN assures the safety of most foods and dietary supplements by regulating food additives and food labeling, specifically the "Nutrition Facts" panel typically seen on packaged foods. Also, CFSAN evaluates products that are used in food handling and storage, referred to as "food contact substances”. In addition, CFSAN provides services related to field programs, agency administrative tasks, scientific analysis and support, and policy, planning and handling of critical issues related to food and cosmetic products to consumers, domestic and foreign industry, and other outside groups.

To perform its core responsibilities, CFSAN uses the mission‐critical Food Applications Regulatory Management (FARM) System to review pre‐market submissions for food ingredients under the Food, Drug, and Cosmetic (FD&C) Act, and the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FARM system is available to CFSAN reviewers to access and review industry submissions and conduct analyses with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific substances. Specifically, this system supports CFSAN’s Office of Food Additive Safety (OFAS) and the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in their review of a wide variety of submissions and petitions submitted by regulated industry. FARM is essential in making regulatory safety regulatory safety decisions.

2. Contract Type This is an 8(a) Indefinite Delivery Indefinite Quantity (IDIQ) type contract with a base period and four ordering periods being processed under a Partnership Agreement (PA) between the Department of Health and Human Services (HHS) and the Small Business Administration (SBA), under which the SBA has delegated to HHS, authority to enter into 8(a) contracts directly with eligible 8(a) firms in accordance to Section 8(a) of the Small Business Act [15 U.S.C. 637(a)].

The assigned SBA Requirement Number is 0353/14/400169.

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.

The FDA has chosen to pursue an IDIQ contract to reduce lead time to award task orders and maximize the flexibility of selecting contract types appropriate to the specific tasks under consideration.

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 $25,000,000.00.

4. Pricing Terms The unit prices specified in an IDIQ task order shall be derived from Attachment 3, IDIQ 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 labor rates 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. In no event shall the Contractor perform, or be paid for any item(s) which exceeds the obligated amount of the contract or order nor the maximum contract ceiling.

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

5. Discounts 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.

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6. Material Handling Fee There is no material handling fee.

II. CONTRACT ADMINISTRATION DETAILS

7. Period of Performance Base Period: 12 months Ordering Period 1: 12 months Ordering Period 2: 12 months Ordering Period 3: 12 months Ordering Period 4: 12 months

Although task orders may be issued at any time during the ordering period, one (1) constraint apply to the period of performance for task orders. The period of performance for a task order may not go beyond one (1) year after the end of the ordering period.

8. Place of Performance The contractor may be required to work at the Contractor site or Government site. Each task order will specify the location of where the work is to be performed.

The contractor will be required to interact with FDA staff in multiple locations primarily throughout the Washington DC metropolitan area.

9. Observance of Legal Holidays & Other Government Closings Recognized Federal Holidays – The Contractor is not required to provide on‐site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area (unless otherwise specified in the task orders):

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans’ Day Thanksgiving Day Christmas Day

Inclement Weather – The Contractor is not required to provide on‐site service on days when the Federal Government is closed due to inclement weather. 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.

Each task order will contain instructions on what to do on those days when the Contractor is not permitted to report for work on‐site because of a closure as determined above.

10. Contract Management Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contract 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 executed by the Contracting Officer.

The Contractor is advised that only the Contracting Officer can change or modify the contract 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.

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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.

11. Government Points of Contact

11.1. Address and phone number of the Contracting Staff:

For the IDIQ Contract:

Contract Specialist: Contracting Officer (Alt POC):

Syntoria L. Spencer Linda Alexander‐Giles 5630 Fishers Lane, Room 1071 5630 Fishers Lane, Room 1084 Rockville, MD 20850 Rockville, MD 20850 Phone: 301.827.6772 Phone: 301.827.7048 Email: syntoria.spencer@fda.hhs.gov Email: linda.alexander‐giles@fda.hhs.gov

11.2. 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

11.3. Task Order COR

For each task order, a Task Order COR will be assigned. The Task Order 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 14; and, (7) reviewing of invoices/vouchers.

The Task Order COR does not have authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Task Order COR designation.

Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction in accordance with section 14; 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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12. 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:

DUNS#:

TIN:

13. 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.

Constitutes a change as defined in the applicable contract clause entitled: FAR 52.243‐1 “Changes ‐ Fixed Price”

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

In any manner which may cause an increase or decrease in the total estimated contract cost, fixed‐fee, 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”.

14. 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 II, item #11.1 above.

15. Invoicing Procedures

15.1. The Contractor shall submit all invoices to all addresses in the manner specified below.

Acceptable methods of delivery include mail and hand delivery. Electronic invoices are not accepted.

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A. One (1) copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Attention: Syntoria L. Spencer 5630 Fishers Lane Room 1071, HFA‐500 Rockville, MD 20857

B. One (1) copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “Courtesy Copy Only”

U.S. Food and Drug Administration

Office of Financial Management

Attn: TBD

1350 Piccard Drive

Rockville, MD 20850

Invoices submitted under this order 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:

A. Name and address of contractor;

B. Invoice date and invoice number;

C. Purchase order/contract number;

D. Invoicing type: 2‐way match;

E. Description, deliverable, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

1. A period of performance for which costs are claimed;

2. Itemized travel costs, including origin and destination;

3. Any other supporting information necessary to clarify questionable expenditures;

F. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

G. Terms of any discount for prompt payment offered;

H. Name and address of official to whom payment if to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

I. Contact information of person to notify in event of defective invoice;

J. Taxpayer identification number (TIN) and DUNS number;

K. Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account which funds are to the deposited;

L. Name of the FDA COR as referenced on the order;

M. Any other information or documentation required by the purchase order/award;

N. Contractor X is is not required to attach an invoice log to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

1. All invoices submitted to date under the subject contract award and under the task order, including the following:

i. Invoice number, amount, and date submitted; and

ii. Corresponding payment amount and date received.

2. Total amount of all payments received to date under the contract number and under the purchase order number.

O. Payment schedules for firm fixed price task orders will be determined at the task order level.

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Questions regarding invoices should be directed to the FDA finance/payment office at: 301‐827‐3742, 866‐807‐3742, or fdavendorpaymentsteam@fda.gov.

15.2 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.

15.3 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.

15.4 Contract Reporting

Financial reports shall be submitted by the contractor with the invoices for labor hour task orders in accordance to the expenditure categories below:

Labor hours and total labor charges for each labor category for the current period and cumulative cost for the total contract to date, with accompanying breakdown by individual, hourly rate, # of hours worked, and employment status (prime or subcontractor/consultant).

Cumulative total for all cost categories (i.e., labor, travel)

Contract ceiling, funds obligated, and percentage expended to date

Estimate to complete

Travel –Include all direct cost to travel including transportation subsistence and miscellaneous expenses.

The following information shall be submitted (Name of traveler and purpose of trip; Place of departure, destination and return, including time and dates; and total cost of trip

16. Ordering Processes and Procedures

16.1. 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 Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer (CO).

16.2 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:

A. FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RFTOP via email. The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (FFP), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

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

C. 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.

D. 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. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

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

F. 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.

17. Travel Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost (except Firm Fixed Price task orders) in accordance with the Federal Travel Regulation.

17.1 Area of Travel ‐ Performance under this Agreement 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

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

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

17.3 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.

17.4 Per Diem ‐ Per diem for travel on work assigned under this contract will be reimbursed to employees consistent with company policy, but not to exceed the amount authorized in the Joint Travel Regulations.

17.5 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.

17.6 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.

17.7 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

14‐223‐SOL‐00003 Page 10 of 46 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.

18. Government Furnished Property (GFP) The Government will provide laptops Personal Identity Verification (PIV) cards (badges) and appropriate network accounts with the specified constraints to be used by the contractor to perform work required by this task order. The contractor personnel shall comply with FDA regulations relating to the use of government equipment. The government will provide access to personal computers and printers when the contractor is required to perform work on the government site.

In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf.

19. FDA 1335 PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006)

19.1. 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.

19.2. 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" 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 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 contract.

The position risk levels for this contract are Public Trust Positions ‐TBD by each individual task order.

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 http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf�

14‐223‐SOL‐00003 Page 11 of 46 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 Project Officer 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.

19.3. 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 contract will be performed:

a. 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

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

Food and Drug Administration Physical Security Branch.

FDA White Oak Command Center 10903 New Hampshire Avenue Silver Spring, MD 20993 301‐796‐2414

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.

19.4. 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.

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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, 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:

Food and Drug Administration OSO/Office of Security Operations Physical Security Branch.

FDA White Oak Command Center 10903 New Hampshire Avenue Silver Spring, MD 20993 301‐796‐2414

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 Project Officer.

19.5. 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.

CHARTS A & B ARE APPENDED TO THIS CLAUSE

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

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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

Project Officer.

Sponsorship must be provided by FDA Project Officer.

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 5600 Fishers Lane

PKLN 15A‐22, HFA‐640

Rockville, MD 20857 **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

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 CO

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

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

*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

U.S. 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

14‐223‐SOL‐00003 Page 14 of 46

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

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

FDA Form 3391 ‐ FDA Security Card Access Request

Project Officer.

Sponsorship must be provided by FDA Project Officer.

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 5600 Fishers Lane

PKLN 15A‐22, HFA‐640

Rockville, MD 20857

**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

PKLN 15A‐22, HFA‐640

Rockville, MD 20857

(301) 827‐5502, ‐5521, ‐5507, ‐5508

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.

Personnel Security Branch 5600 Fishers Lane

PKLN 12A‐43, HFA 630

Rockville, MD 20857

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

No appointment necessary

(301) 827‐9615

14‐223‐SOL‐00003 Page 15 of 46

20. FDA 1350 ACCESS TO NON‐PUBLIC INFORMATION

20.1. All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non‐ Public Information (NPI) Agreement (Form FDA 3398) provided as an attachment to this contract (See Section J). 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 TO COR and the TO CO. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand‐deliver it to the TO COR ten (10) days prior to said new employee's commencement of work on this contract.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non‐public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

20.2 Briefings

An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor and subcontractor employees. The briefing will stress: (1) the importance of protecting non‐public information; (2) specified computer/IT 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 their responsibility to protect it. The briefing shall stress that the information is non‐public and shall not be disclosed to any unauthorized party. 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; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees.

If this is an information technology/telecommunications (IT/TC) contract, in addition to the above briefings, the FDA Project Officer and the FDA Center/Office Information Systems Security Officer (ISSO) will brief Contractor and subcontractor personnel on security measures required pertinent to any hardware/software being utilized.

Furthermore, appropriate Contractor and subcontractor personnel shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length, and attendance at one (1) course is sufficient. This training will be provided at no cost to the Contractor.

20.3 Physical Security Requirements for Releasing Non‐Public Information Under the provisions of Title 21, United States Code, Section 331(j), the contractor shall establish and maintain comprehensive security measures for controlling access to non‐public information released under a contract involving the processing of such information.

The contractor shall be required to submit a physical security plan with their proposal. The plan shall provide written procedures which detail the instructions issued to contract employees on the following:

1. safeguarding material during use;

2. safeguarding material at all other times;

3. accounting for material

a. tracking procedures,

b. created in‐process;

4. storage control;

5. key control;

6. area security;

7. visitor control;

8. receipt and transmittal of material;

9. reproduction of material;

10. destruction of material;

11. recording logs;

12. response to emergency situations;

13. compromise of information; and,

14. administrative controls.

14‐223‐SOL‐00003 Page 16 of 46

This clause applies to the contractor, any subcontractors, and any consultants. Non‐public information will be released to only those persons who will be using the contractor’s approved facility unless the off‐site facility has been reviewed by the FDA Physical Security Staff and approved in writing by the FDA Physical Security Office.

For transmittal of documents the contractor shall adhere to the following:

1. Documents to be transmitted internally shall be transmitted on a person‐to‐person basis between approved employees only.

2. Documents to be transmitted outside the contractor’s facility shall be double‐wrapped with the inner wrapping marked “FDA Privileged Information – Access Controlled”. The names and addresses of the sender and addressee shall be typed on both the inner and outer wrappings.

3. Documents to be transmitted back to the FDA or to another address designated by the FDA shall be transmitted by an approved employee or by U. S. Registered mail (return receipt requested). It shall be double‐wrapped or wrapped by such a method as specifically approved in writing by the FDA Physical Security Office.

4. A receipt log shall be maintained for all external transmittals.

The contractor shall follow up all transmittals in order to obtain signed receipt within five (5) working days of transmittal. Failure of recipient to furnish such receipt shall be reported to the FDA Physical Security Office within ten

(10) working days of transmittal.

No non‐public information will be released to the contractor unless all required security precautions have been met [as demonstrated during an inspection by the Food and Drug Administration (FDA) Physical Security Staff], and written procedures for enforcing them have been provided by the contractor and approved in writing by the Physical Security Staff. The FDA Physical Security Office will notify the contractor of the approval.

When the contractor facilities have a current certification from the Defense Contract Administration Services/Defense Logistics Agency (DCAS/DLA) as a “Secret” or higher classification, such rating will satisfy the FDA security requirements for the contractor’s facility. Loss of such certification during the period of the contract will be cause for a possible issuance of a Stop Work Order pending review by the FDA’s Physical Security Staff of the contractor’s facility. The contractor shall notify the FDA Physical Security Office in the event the DCAS/DLA rating is expected to be terminated.

Pending the outcome of any subsequently required investigation, additional requirements on the contractor shall include, but not be limited to, the following: restrictions on access to data by contractor employees, subcontractor employees, and consultants; special storage requirements; restrictions on transmission and disclosure of information;

changes in periods of retention and in methods of destruction of source documents or related material; and disclosure statements for all contractor employees, subcontractor employees, and consultants.

The FDA Physical Security Staff will review the contractor’s facility and assess the contractor’s compliance.

Recommendations for bringing noncompliant areas into compliance will be provided to the contractor by the FDA Physical Security Office.

The Contractor shall make any changes necessary within thirty (30) days after written notice from the FDA Physical Security Office in order to comply with FDA security requirements. When appropriate changes have been made the Contractor shall contact the FDA Physical Security Office to request further review by the FDA. The FDA Physical Security Office will notify the Contractor in writing of the outcome of the second inspection. Failure of the contractor to satisfy FDA security requirements within thirty (30) days after the first written notification from the Contracting Officer may be cause for termination of the contract.

The contractor shall designate a Security Representative to act as liaison between the contractor and the FDA on all security‐related matters. This includes personnel changes, personnel terminations, disciplinary actions, etc. The name of the Security Representative shall be provided in the offeror’s proposal.

14‐223‐SOL‐00003 Page 17 of 46

In addition to the above, if this is an automated data processing/telecommunications (ADP/TC) contract, special requirements are necessary. Contractor and subcontractor employees and consultants participating in the design, operation, maintenance or use of FDA automated information systems or ADP/TC resources shall comply with the DHHS Automated Information Systems Security Program Handbook. Chapter VII, entitled, “Personnel Security/Suitability and Training,” which establishes criteria for assigning positions to the three (3) computer/ADP position risk levels: Level 6, high risk public trust position; Level 5, moderate risk public trust position; and Level 1, low risk position. Chapter VIII, entitled, “AIS Facilities,” requires contractors to meet or exceed the security requirements described therein.

All contractor, subcontractor and consultants assigned to this contract and working in a FDA facility will…