CFSAN_IDIQ_FDA-SOL-_Chemical_Ananlysis_Services_(Final_RFP)_JHC_05232016_(2).docx

Solicitation Number: FDA-2016-Chemical Analysis Services for CFSAN.

REQUEST FOR PROPOSALS

for

CHEMICAL ANALYSIS SERVICES

at the

FDA CENTER FOR FOOD SAFETY AND APPLIED NUTRITION – CFSAN

RFP NUMBER: FDA-2016-SOL-1160970

Table of Contents

Section 1-Contract Type ………………………………….......2 THRU 5 Section 2-Specifications and Statement of Work……………..5 THRU 19 Section 3-Contract Clauses………..…………………….……19 THRU 38 Section 4-List of Attachments………….……………….……38 THRU 38 Section 5-Solicitation Provisions……. ……………………...38 THRU 40 Attachments...…………………………………………….......41 THRU 42

Issued: By Emmanuel T. Mbah Food and Drug Administration, Division of Acquisition Program, Facilities Support Branch

NOTICE TYPE: COMBINED SYNOPSIS/SOLICITATION

Subject: CHEMICAL ANALYSIS SERVICES AT THE FDA CENTER FOR FOOD SAFETY AND APPLIED NUTRITION – (CFSAN), IN THE WASHINGTON D. C METRO AREA.

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

Solicitation Number # FDA-2016-SOL-1160970 is being issued as a Request for Quotation (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005 – 88. This requirement is being solicited under full and open competition using the Simplified Acquisition Procedures per FAR Subpart 13.5. The associated NAICS Code is: 541380 - (Testing Laboratories).

The U. S. Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) is seeking to procure Technical Services for “Chemical Analysis”.

Section 1

1.1 Contract Type This is an Indefinite Delivery, Indefinite Quantity (IDIQ) Type Contract for Chemical Analysis Services. The structure of the contract shall be a Base Period of One (1) Year, followed by Four (12 Months) Option Periods, totaling Five (5) Years, for the life of the contract. The Contractor shall furnish all necessary facilities/personnel, and shall perform all tasks necessary for the “Chemical Analysis Services” requested by FDA, at the Center for Food Safety and Applied Nutrition (CFSAN), in the Washington DC Metro Area.

1.2 Contract Ceiling The Government shall pay the Contractor the fixed price of $1,000.00 as the guaranteed minimum amount for the life of the contract, which shall be incorporated as part of the first task order. This amount can only be claimed at the end of the contract period if the Contractor does not receive any task orders under this IDIQ contract. The maximum value of the contract shall not exceed $4,000,000.00.

1.3 Funding Funds for the services provided shall be obligated, at the task order level, as they become available, or excess funds de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The Contractor shall only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications.

1.4 Task Orders Individual Task Orders shall be issued as requirements occur. Task Orders shall specify work to be performed and reflect the rates of the proposed tests in effect when the task order is issued (in accordance with the provisions contained in Section 2 of the IDIQ contract and the awarded task order). The Contractor shall perform all services in accordance with the task order performance work statement/specifications, which shall be included in the Task Order. All Task Orders shall be fixed price. The period of performance of a Task Order may extend after the IDIQ contract’s expiration date.

1.5 Pricing The pricing chart below outlines the various types of anticipated Laboratory Analytical Tests required. The Contractor shall use the chart to propose fixed rates that shall apply throughout the life of the contract. It is anticipated that FDA shall request one test each per listed Analytical Methodology. The following List of Analytical Test Methods shall be required:

(*1) (See table in Section 2.4.E for details about methods required; acronyms listed above are:

0. LC/MS: Liquid chromatography/mass spectrometry

0. LC/MS/MS: Liquid chromatography/tandem mass spectrometry

0. HPLC: High performance liquid chromatography

0. ICP-MS: Inductively coupled plasma mass spectrometry

0. IC/ICP-MS: Ion chromatography/Inductively coupled plasma mass spectrometry

0. GC/MS: gas chromatography/mass spectrometry

0. GC/FID: gas chromatography/flame ionization detector

0. HPLC-UV: High performance liquid chromatography/UV/visible detector.

1.6 Offerors shall use the chart in Section 1.5 above to describe the sample preparation methodologies, analytical methods, and instrumentation in accordance with Section 2. The price per test shall be based on the chemical test described and the analytical method. The contractor may charge CFSAN the cost of performing any analysis outlined except where noted. The quoted price shall apply to all additional tests, if any, by simply multiplying the price by the number of tests during the period of performance in question.

SECTION 2 – SPECIFICATIONS STATEMENT OF WORK

2.1 General Description The U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), and its various offices nationwide, including the Office of Regulatory Science (ORS), the Office of Food Safety (OFS), the Office of Food Additive Safety (OFAS) and the Office of Compliance (OC), has a need to obtain information about the concentrations of chemicals in a wide variety of foods, dietary supplements and cosmetics, through the collection of food, dietary supplements and cosmetic samples, and their subsequent analysis by chemical analytical methods to be specified in each task order.

2.2 Background

In order to support the FDA’s overall mission, CFSAN is required to produce information about the nature of chemical contaminants in food. Over the past several years, the agency has faced a wide range of issues related to direct and indirect contamination of food that have required information on the concentrations of specific chemicals. In many cases, the type of information required is a survey of the concentrations of contaminants in order to provide CFSAN with information necessary to formulate policy and to assess potential risks. In the past, this information has been provided by scientists within CFSAN:

i) Through small scale in-house surveys;

ii) Through contracts with outside laboratories and

iii) Through surveys conducted by the FDA’s Office of Regulatory Affairs on behalf of CFSAN.

The information from these surveys is not used for direct regulatory action, but is instead used to make decisions about scientific issues associated with food safety problems and to guide policy. For example, surveys in the past were used to inform the agency about the nature of acrylamide concentrations in food, and were followed in 2011-2014 by a larger study, done by a contract laboratory, which established the concentrations of acrylamide in a larger set of representative types of foods. This information was used to develop guidance about ways to reduce the occurrence of acrylamide in foods. Future studies shall examine how guidance and policy have affected the concentrations of this chemical in foods. In 2011-2014, contract laboratory analysis was also used to assess concentrations of inorganic arsenic in rice and rice products, as well as fruit juices, in order to obtain information used in developing risk assessments. Similar surveys were conducted to assess concentrations of 4-methylimidazole (4-MEI), potassium bromate, semicarbazide and color additives in various foods, in order to address different programmatic needs within CFSAN. It is anticipated that CFSAN will continue to have such needs over the next five years.

2.3 Scope

The objective of this contract is to develop a capability to support CFSAN’s research by rapidly assessing the quantities of specified chemicals in foods, dietary supplements, and cosmetics through surveys of these commodities. The purpose of these surveys is to develop a better understanding of the quantities of chemicals and their distribution. The types of samples to be collected for these studies include food products from across the United States, including fresh fruits and produce, packaged and processed foods of all types, dietary supplements and cosmetics. The analytical targets of these studies include chemical contaminants in foods (e.g. pesticides, industrial chemicals), direct food additives and indirect food additives (those produced by processing or transfer from packaging), deliberate adulterants, nutrients, naturally occurring chemical components (such as metals), as well as the chemical constituents of dietary supplements, botanical extracts and cosmetics. The analytical methodology for any specified study will be established and provided by CFSAN, and shall include methods based upon state-of-the-art analytical techniques, including many based on instrumental analysis with various types of separation techniques and spectrometers. The offeror must possess an ISO 17025 Accreditation or equivalent.

2.4 Technical Requirements; Chemical Analysis:

The Contractor shall provide all services necessary or incidental to the chemical analysis services requested by the FDA at CFSAN. In addition, the Contractor shall furnish the necessary professional personnel, materials, services, facilities, and do all things necessary for or incidental to the performance of the work.

Task orders shall include, but not be limited to the following:

CFSAN shall specify the types of samples, quantities (between 50 and 1500), analytical methodology and data reporting requirements with each specified task.

The contractor shall perform the following tasks:

A. Sample Collection: Collect raw, minimally processed (e.g. bagged), and processed/packaged foods, dietary supplements and cosmetics from local supermarkets and stores in major metropolitan areas in some parts of the United States. Cities chosen may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. CFSAN shall specify the type of commodity, the brand distribution, lot number and manufacturing date distribution, quantity and geographic location of the samples. While the geographic distribution is not expected to be extensive, the ability to obtain samples from major metropolitan areas is required.

1. Collection of food samples:

a. Samples may be collected with specific requirements as to geographic location.

b. Sample collection may occur in different geographic areas in cases where there are significant regional variations in the way foods are processed.

c. In some cases, there may not be a requirement to collect samples at different locations. For some types of questions, it is sufficient that national brands be purchased from multiple lots, but as long as the lot requirements are met, they could all be purchased from the same place.

d. Sample Collection Costs: Sample collection costs are to be priced in a way that the cost per sample is known at the time the task is awarded.

e. Sample logging: When samples are collected, the following information will be obtained.

1. Sample numbers assigned by FDA or by the Contractor.

2. Name of the product and size of the package (e.g., Diet Coke, 2 liters).

3. Date and location of sampling.

4. Readable digital photographs or photocopies of the food packaging, as purchased, to include front of package, nutrition information panel and ingredient list. The Contractor shall retain all product packages for the analyzed food products until FDA deems the digital photographs to be acceptable.

5. Record of lot numbers/production codes and expiration dates (where applicable).

6. Serving size from product label.

7. Sampling portion where applicable (e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

f. When samples are collected, digital photographs must be obtained for each item collected:

1. Collected items shall be assigned a sample ID #, which shall be carried throughout the entire analysis process.

2. Photographs shall be taken of the front of the items so that the specific items and brand are clearly identifiable.

3. Photographs shall be taken of the ingredients panel and the Nutrition Facts label, as well as the Uniform Product Code (UPC).

4. Photographs shall be taken of preparation instructions, if the samples are to be prepared by the vendor.

5. All digital photographs must be available in BMP, JPG or similar digital format. Each digital photograph must be named in such a way that the Sample Identification Number (SIN) occurs at the beginning of the file name.

6. The Contractor must be able to upload the digital photographs to an FDA-selected site using FTP or similar protocol.

g. In some cases, the vendor shall be asked to prepare foods, according to package instructions, prior to analysis. Minimum suggested food preparation facilities (or access thereto) include mixers, pans, cookie sheets, utensils, fryers and ovens to prepare cakes, cookies, not ready to eat foods that must be cooked in the oven (French fries, snack foods, etc). In such cases, foods will be prepared as they would normally be consumed (e.g., all frozen meals cooked, and dry mixes prepared according to package directions prior to analysis), unless otherwise directed by CFSAN. Food preparation steps should be documented. A brief description of the sample processing (e.g., homogenization, filtration, extraction, sample size) of each sample, prior to analysis, shall be recorded and included in sample data.

h. If CFSAN sends samples to the Contractor directly, CFSAN shall be responsible for the cost of shipping.

i. An update of the sample collection status for any particular task must be provided in a spreadsheet at the end of each month, together with the monthly reports requested in Section 2.4 (c).

B. Standard analyte analysis per price list. The Contractor shall perform analysis of samples for analytes specified in the standard price list (see above table, in Section 1.5, wherein chemicals and methods are specified). The number of analyses identified in the task order shall include the maximum number of collected samples to be analyzed. The Contractor shall use a Quality Control plan or similar method that shall be specified with each task order.

1. A calibration curve shall be generated before, during or after each set of analyses, per the contractor’s usual procedures (which must be outlined in the response). The Contractor shall bear the cost of generating the calibration curve (s).

2. Spike recoveries shall be performed by addition of standards to the food matrix every 20th sample. If less than 20 samples are analyzed for a food category, spike recoveries must be determined on at least one sample in the food type category. Spike concentrations shall be specified in the task order under the QA/QC plan, but in general spike concentrations will be at the midpoint for the working range for the contaminant in question. At a minimum, the value calculated for the recovery must be within ± 25% of the expected recovery. If the recoveries are not acceptable, appropriate actions should be taken and the spike recovery should be re-determined (vendor to assume the cost). The amount (concentration or mass) of analyte added to the sample must be reported with the results in order to allow an independent determination of the recovery.

3. A calibration check standard shall be analyzed every 10th sample to monitor retention time and quantitative accuracy. (At a minimum, calibration check samples must fall within the 95% confidence limits determined from the standard curve). The calibration check standard must be run at a concentration that is near the mid-point of the analytical calibration curve. If there is a failure to meet this criterion, appropriate actions must be taken and the standard must be re-analyzed. Additional failures require that a new calibration curve (contractor assumes the cost) be prepared and all samples prior to the QC failure to be re-analyzed. The true value (i.e., expected value) of the calibration check should be reported with the results to allow for an independent determination of the QC result.

4. For each separate food category (as defined by CFSAN when the task order is placed), replicate (duplicate or triplicate) analysis of a sample will be performed as specified in the task order. The replicate analyses will occur at either the 20th sample within the food category or approximately mid-way through the list of samples for a particular food category (if a food category contains less than 20 samples). The relative standard deviation for the results shall be less than 15%.

5. The Contractor, for purposes of quality control, may run their own standardized QC spike sample (at their own expense).

6. Failure of any of QA/QC samples to meet method performance measures shall require an explanation of what was done to correct the method and shall require reanalysis of the samples analyzed prior to loss of method control measures.

7. The Contractor shall provide CFSAN with a control chart for the QC samples.

C. Data reporting. In general, the Contractor shall report data from analysis according to the procedures outlined below, on a monthly basis. The Monthly Report must also include an update of the sample collection status for any particular task. More information on data reporting shall be provided in each task order.

1. Reports (as specified in the assigned analytical method requested) shall be provided to CFSAN at the end of each month (on the Last Business Day). Description of report format and content shall be specified at the time of order, but will be similar to that described below. Whenever possible, all samples for a particular food category should be purchased, analyzed, and results provided together. The following minimum data reporting requirements must be met:

a. Results and Certificates of Analysis (COA). At the end of each month (on the Last Business Day), a results Spreadsheet (Excel), raw data files, quantitation files and photocopies or photographs of product packaging, and analysis of a specified sample set (food type, group, etc, as specified in each task order, shall be provided. COAs, spreadsheets, raw data and product package photos will be uploaded to a server that CFSAN will provide and identify.

b. The Contractor’s Results Spreadsheet (in Excel described above) shall include the following information:

1. Assigned Sample Number (ASN).

2. COA number on which the sample appears

3. Name of the product (For quantitation check standards, concentration or quantity can be used in place of the product name or a separate column can be used to show this information).

4. Size of the package.

5. Date of purchase.

6. Location of purchase.

7. Lot number or production code.

8. Expiration date (if applicable).

9. Serving size from product label.

10. Sampling portion where applicable (e.g., center or heel slice of bread, whole breaded fish fillet as packaged, a composited frozen dinner).

11. Analytical results in appropriate units (typically mg/kg or µg/kg) of the analyte in the food as consumed.

12. For each spike analysis, information on the amount spiked, the result, and the percent recovery

13. File name or link for digital photographs of product label (front of package, nutrition information panel and ingredient list).

14. Raw data file name for each sample number (may be the same for multiple samples, but MUST include raw data for calibration curves used to generate quantitative results)

15. Quantitation file name if separate quantitation files are generated D. Reports/Deliverables The Contractor shall provide the reports (including an update of the sample collection status for any particular task) on the Last Business Day of each month, and reported to FDA on Certificates of Analysis (COA) and in results spreadsheets. Task Orders shall specify the collection of a number of samples and the analysis of those samples. The deliverables shall be certificates of analysis and results spreadsheets for the specified analyses. For example, a task order might specify the collection of 400 samples and analysis of 400 samples plus the associated QA/QC samples (80 additional analyses.

The contractor shall submit the following reports/deliverables, (Unless otherwise noted. Calendar days apply):

Unless otherwise specified, all reports or copies of reports shall be delivered to:

Department of Health & Human Services Food and Drug Administration

ATTN (COR) TBD

Office of Regulatory Science FDA/Center for Food Safety and Applied Nutrition (CFSAN) 5100 Paint Branch Parkway 2D-043/HFS-707 College Park, MD 20740 and

Department of Health & Human Services Food and Drug Administration ATTN: Emmanuel T. Mbah, Contract Specialist Facilities Support Branch, DAP 5630 Fishers Lane, Room 2060A, HFA-500 Rockville, MD 20857-0001 Emmanuel.mbah@fda.hhs.gov E. Format of Monthly Report (MPR):

A report of results shall be submitted (as Certificates of Analysis, on a spreadsheet containing results to date, data files and photos) on monthly intervals by the (Last Business Day of the month), beginning from the contract award date unless otherwise stated on the task order. The report shall be in the following format:

(a) A cover page containing:

i. Contract Number and Title; and Task Order Number

ii. Type of report, sequence number of report, and period of performance being reported; iii. Contractor’s name and address;

iv. Name of Author(s); and

v. Date of report

(b) A summary of the samples collected to date for each task, COAs, results spreadsheets, raw data files, quantitation files and photographs submitted in the current report, with the files names and the type of analysis performed.

c) Spreadsheets with summaries of the results obtained in the previous month, to be formatted as noted in section 2.4.C.1.b (Contractors Results Spreadsheet), Certificates of Analysis, Raw Data Files, Quantitation files and label photographs.

F. Instructions for Reports All postage and fees related to distribution of deliverables, including forms, reports, etc. shall be paid by the Contractor.

G. The following table is provided for informational purposes regarding the analytical methods required:

Nyman PJ, Diachenko GW, Perfetti GA, McNeal TP, Hiatt MH, Morehouse KM. J Agric Food Chem. 2008 Jan 23;56 (2):571-6.

1 ppb

Pesticide Residues in Foods by Acetonitrile Extraction and Partitioning with Magnesium Sulfate Gas Chromatography/Mass Spectrometry and Liquid Chromatography/Tandem Mass Spectrometry First Action 2007 10 ng/g

Phthalates (BBP, DBP, DEHP, DNOP, DINP, DIDP, DHEXP and DCHP)

2.5 Contractor Quality Control (CQC)

The Contractor shall perform Quality Control (QC).

i) Quality Control. The Contractor shall control the quality of their work.

2.6 Government-Provided Quality Assurance i) Quality Assurance. QA is an FDA oversight process where the FDA COR/CO holds the Contractor accountable for the execution of the approved QC Plan. The Government will use all materials deemed necessary to ensure that the Contractor’s employees are in constant state of awareness and readiness. These methods may include surveys of building tenants regarding the contractor’s performance, including professionalism, courtesy, and knowledge of their assigned duties. In the event a serious breach of assigned duty by the contractor’s employee(s) is identified during a quality control exercise, the Contracting Officer and/or Contracting Officer’s Representative shall immediately contact the Contractor to discuss the Government’s findings and the steps the Contractor will take to correct the problem(s).

2.7 Task Order Issuance Procedures

i) The Government shall issue task orders when the need arises, in accordance with the pricing schedule in Section 1.6, regardless of the location or geographic area.

2.8 Performance Period:

The contract will be for an initial base period of one year and four potential option periods, each 365 calendar days. The options periods, if exercised, shall run consecutively and at the discretion of the Government. The actual period of performance for a Task Order may extend beyond the contract expiration date. Task Orders under this contract may be signed by the Contracting Officer at any time during the contract base or option period, provided that the total maximum dollar value of the base year plus options years have not been exceeded. The Contracting Officer shall not award a task order or a change to a task order if the performance period will extend beyond 365 calendar days of the contract expiration date including the final option period.

If the Government exercises its option period (s) pursuant to FAR Clause 52.217-9, of this contract, the period of performance shall be extended as listed below. Options are not guaranteed.

Option Year Number Period of Performance

The exact dates shall be finalized after award.

2.9 Place of Performance

The required services shall be performed at the Contractor’s facility to be determined prior to contract award.

SECTION 3 - CONTRACT CLAUSES

3.1 FAR 52.212-4 - Contract – Terms and Conditions – Commercial – Items (May 2015) Alternate I (May 2014) and below addendum applies to this acquisition.

3.2 FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

3.908-9,

3.3 FAR 52.216-18 - Ordering (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from date of award through option year IV prior to the expiration date.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

3.4 FAR 52.216-19 - Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount less than $2,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor -

(1) Any order for a single item in excess of $2,500,000.00

(2) Any order for a combination of items in excess of $2,500,000.00; or

(3) A series of orders from the same ordering office within thirty (30) days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five (5)days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

3.5 FAR 52.216-22 - Indefinite Quantity (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided that the Contractor shall not be required to make any deliveries under this contract after the fifth year.

3.6 FAR 52.217-8 - Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 (Ten) days, within which the Contracting Officer may exercise the option].

3.7 FAR 52.217-9 - Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 (Ten) days, within which the Contracting Officer may exercise the option]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 (Ten) days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 (Five) years.

3.8 Security and Privacy

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval from the Government. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation. The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the COR, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each Contractor/Subcontractor employee who may have access to non-public Department information and/or sensitive information under this contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COR or designee prior to performing any work under the contract. The COR or designee will inform the Contractor of the forms and training that are required. However, it is the responsibility of the Contractor to assure that such forms have been signed.

3.9 Holidays FDA personnel observe the FDA following days as holidays:

1. New Year's Day

1. Columbus Day

1. Washington's Birthday

1. Veterans' Day

1. Memorial Day

1. Thanksgiving Day

1. Independence Day

1. Christmas Day

1. Labor Day

1. Martin Luther King's Birthday

1. Any other day designated by Federal statue

1. Any other day designated by Executive Order

1. Any other day designated by the President's Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract.

Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the contract. In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor will direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the contract for employees whose regular time is normally a direct charge if they continue to perform on contract work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

3.10 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration. FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the Contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.