FDA-SOL-1116253_final.doc

FDA-SOL-1116253

Solicitation Number: FDA-SOL-1116253 Subject: Environmental Sampling and Analysis Description

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

Solicitation FDA-SOL-1116253 is being issued as a request for proposal (RFP). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-69. This requirement is being solicited as a Total Small Business Set-aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712, with a small business size standard of 500 employees.

The U. S. Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) is seeking to purchase environmental sample collection and microbial analysis of regional, national and international areas important to pre-harvest produce safety.

1.1 Contract Type

The government intends to award no more than two (2) Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts. Task/delivery orders may be fixed price, labor-hour, or time and materials.

1.2 Contract Ceiling

The IDIQ guaranteed minimum amount will be $1,000.00 over five (5) years inclusive of options. The contract maximum ceiling amount will be $8,000,000.00 over five (5) years inclusive of options.

1.3 Pricing

The pricing chart below outlines all of the labor categories and the various types of laboratory analysis that shall be required throughout the life of the contract.

The Contractor shall provide services in accordance with the Statement of Work for Global Environmental Sampling and Microbial Analysis.

Pricing Charts:

Base Year

Qty Amount

(includes confirmation)

(includes confirmation)

Option Year 1

Qty Amount

(includes confirmation)

(includes confirmation)

Option Year 2

Qty

Amount

(includes confirmation)

(includes confirmation)

Option Year 3

Amount

(includes confirmation)

(includes confirmation)

Option Year 4

Amount

(includes confirmation)

(includes confirmation)

Total All

Year

Total

Opt Year 1

Total Opt Year 2

Total Opt Year 3

Total Opt Year 4

Total Total

All

(includes confirmation)

(includes confirmation)

The material handling fee applicable to other direct costs is: ________

Note: Reference Section C for a full description of each labor category.

Travel and Per Diem authorized under this contract shall be reimbursed in accordance with the Federal Travel Regulations or, in the case of foreign travel, the Standardized Regulations (See Section 4.1.15).

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Statement of Work for Global Environmental Sampling and Microbial Analysis

2.1 Background

Despite the implementation of produce safety practices foodborne outbreaks of fresh, ready-to-eat produce continues to result in significant outbreaks, illnesses and deaths. An estimated 14% of all foodborne outbreaks reported in North America are attributed to the consumption of raw or minimally-processed fruits and vegetables. This trend is likely to continue for two reasons: (i) the consumption of fresh produce commodities has increased due to the promotion of eating healthful, nutritious foods such as fruits and vegetables and (ii) many of these commodities are consumed raw with no kill step to eliminate any potential pathogen contaminants. Additionally, produce from several of the most devastating recent outbreaks have originated in countries other than the U.S. Over the past 25 years there has been a significant increase in the number of fresh produce commodities that are imported into the U.S. This is mainly due the American consumer’s demand for fresh produce year round. As such 44% of the fresh fruit and 16% of the fresh vegetables consumed by U.S. citizens are now imported from other countries.

Investigation and trace-back of many fresh produce-related foodborne outbreaks often implicates the growing environment or surrounding areas as the source of contamination. It has been demonstrated that many of these foodborne pathogens are capable of surviving for extended periods of time within the soils, waters and sediments in the environment and maintain their ability to contaminate produce and cause illness in humans. Likely sources of pre-harvest contamination include irrigation waters; water used for the topical application of pesticides, fungicides and herbicides; application of untreated manure to the produce fields, even weeks before planting or harvest; runoff water from livestock operations and wildlife intrusion into the produce fields. Contamination of produce remains a complex issue because many of the conditions that promote the persistence and survival of these pathogens in the environment and in planta are not known. A better understanding of the ecology, distribution and persistence of these pathogens in the environment is paramount to gaining a greater understanding of the sources and mechanisms of produce contamination. Also, there is a need to investigate the natural growing environments of the increasing number of imported goods to discern if there are ecological differences between domestically grown produce and internationally grown produce and what measures can be taken to ensure the safety of the imported fresh produce supply. As such the information gleaned from understanding the ecological microcosms in which these pathogens persist is key to understanding the link between a pathogen and a food source as well as to developing stop-gap measures to deter future outbreak events. Thus environmental sampling will provide detailed microbiological insight into sources of contamination that may lead to more effective good agricultural practices (GAPs) and preventative measures unique to this growing region.

2.2 Objectives

The objective of this contract is to obtain environmental surveillance data on the incidence and prevalence of Salmonella, E. coli O157 and non-O157 STECs, and Listeria monocytogenes in pre-harvest agricultural areas. These samples may be taken within the United States and outside of the United States, including but not limited to other North American countries, South America, Europe and Asia.

This project will support FDA’s mission of protecting the public health by generating environmental surveillance data from pre-harvest environments that may lead to the contamination of fresh, ready-to-eat produce and identify risk factors for incorporation into Good Agricultural Practices (GAPs).

2.3 Scope of Work

Furnish all personnel, services, equipment, and such other things, as necessary, to perform global environmental sampling and microbial analysis.

2.4 Tasks

The Contractor’s tasks shall include:

2.4.1 Sample Collection

The Contractor shall collect environmental samples regionally, nationally and internationally that have a broad representation of areas with fresh produce agriculture.

2.4.1.2 The Contractor shall perform sample collection in accordance with the methods indicated on Attachment 2, “Environmental Sample Collection Methods” unless another method is approved by the COR. Sample Collection methods will vary depending on the type of sample and organism and will be determined at the task order level. The contractor shall perform sample collection for the following types of environmental samples (included but not limited to):

· Agricultural soils

· Water and sediments from local streams, creeks, etc.

· Agricultural irrigation water

· Native vegetation

· Produce rhizophere and phyllosphere (i.e. roots, leaves and blossoms)

· Field standing water

· Feces/scat

2.4.1.2 In performing Sample collection, the Contractor shall:

· Collect samples for shipment to the Contractor’s lab(s) for analysis.

· Perform only approved sample collection methods.

· Ship all samples on ice and stored at 4(C until microbiological analysis.

2.4.1.3 The Contractor shall coordinate details regarding where samples will be collected with the FDA COR. The Contractor shall collect sufficient materials to provide subsamples for each of the tests included in the panel of FDA required analyses. Samples shall be collected and transported to the Contractor or FDA for analysis under a limited scope chain-of-custody which would include:

· The name of the person collecting the sample.

· The date the samples were collected.

· The type of environmental sample collected.

· The address and GPS coordinates of where the sample was collected.

· Clear pictures of the area where the sample was collected.

2.4.2 Sample Processing and Analysis

2.4.2.1 The contractor shall perform sample analysis in accordance with the methods indicated on Attachment 3, “Microbiological Analysis methods” unless another method is approved by the COR. Sample analysis methods will vary depending on the type of organism and sample and will be determined at the task order level. The Contractor shall meet with FDA prior to commencing work in order to review the FDA proposed analysis methods. The contractor shall perform microbiological analysis for the following types of organisms (included but not limited to):

· Salmonella (detection/isolation)

· Listeria monocytogenes (detection/isolation)

· Shiga-toxin producing E. coli (STECs) O157:H7 & non-O157 STECs

· Vibrio (detection/isolation)

· Norovirus

· Hepatitis A

2.4.2.2 In performing Sample Analysis, the Contractor shall

· Process the collected samples following methods approved by the COR.

· Pathogens may be tested for presence/absence and/or be enumerated.

· The appropriateness of any method for specific sample types shall be determined in consultation with the CO or COR and no method for the analysis of any sample shall be used without the COR’s consent and will be agreed upon based on the individual task order.

· Store all microorganism isolates at appropriate temperatures before shipment to FDA

2.4.3 Computer Services

The Contractor shall use computer systems that are compatible with FDA's operating system and standard desktop program. FDA's current standard operating system is Windows 7 and standard desktop program is Microsoft Office 2010.

2.5 Contractor’s Technical Work Plan

A technical work plan will be designed and approved working with the FDA COR and other technical advisors at the FDA prior to the commencement of any task order.

Plans may vary and depend on individual task order and may change with each individual task order The contractor shall submit the technical work plan for approval after assignment of each task order and before work commences. The work plan should include:

· Specific sites where environmental samples will be collected

· Proposed dates of environmental samples collection

· Proposed methods of transport of samples from collection site to microbiological analysis site

· Proposed methods of microbial analysis based on sample type and microorganism to be tested for

· Proposed storage of microoganisms before shipment to FDA

2.6 Labor Category Descriptions

Project Manager Manages and is responsible for ensuring compliance with contract rules and regulations. Ensures adherence to master plans and schedules, develops solutions to programmatic problems, directs work assigned to the program from various departments. Ensures the project is completed on time and within budget.

The Government has a preference of a Bachelor’s degree and at least ten (10) years of experience managing research projects involving food sampling, microbial analysis and other quantitative methods for this position.

Lead Scientist

Supervises and works alongside with Scientists and Laboratory Technicians. Directly responsible for overseeing the day to day collection of samples and microbial analyses to be performed. Communicates clearly in written and oral form. Assesses the daily research needs of the Scientists and Laboratory Technicians, applies appropriate analytical methods and prepares reports for the Lead Scientist and Project manager.

The Government has a preference for a Ph.D. in microbiology or related field, at least five (5) years of experience in microbial analysis and at least three (3) years of experience managing research projects involving microbial analysis and quantitative methods for this position.

Senior Scientist

Manages and is responsible for all scientific aspects of a single project, including overseeing quality control. Communicates clearly and articulately in written and oral form. Assesses complex research questions, applies appropriate analytic methods, interprets data and presents study results. Provides extensive experience and judgment to plan and accomplish goals.

The Government has a preference for a Ph.D. in microbiology or a related field, at least ten (10) years of experience in microbial analyses and five (5) years of experience managing research projects involving microbial analysis, and quantitative methods for this position.

Scientist

Performs research activities and other tasks necessary, including quality control, in the laboratory environment for the project, including conducting microbial analysis and molecular analysis. Records daily observations and measurements, prepares reports for Lead Scientist and Senior Scientist.

The Government has a preference for a Bachelor’s in microbiology or related field, at least three (3) years of experience in microbial and molecular analysis, including the isolation and culturing of microorganisms from foods, waters, soils/sediments, etc.

Laboratory Technician

Handles day to day collection of environmental samples and is responsible for recording proper documentation of the sample type, location, etc. as well as collect the required sample(s) requested. Also, handles day to day microbial analysis, including but not limited to the culturing of microorganisms from foods, waters, soils/sediments, etc. and is responsible for recording and documenting the types of analyses performed on each sample and for each organism to be tested for. Works closely with Scientist, Lead Scientist and Senior Scientist on assigned project goals.

The Government has a preference for a B.S. in microbiology or related field, at least one (1) years of experience in microbial analyses including isolation and identification of microorganisms from foods, waters, soils/sediments, etc.

Statistician

Manages all statistical support for the project including but not limited to analysis related to the calculation of sample size and most probable number determination on an as needed basis.

The Government has a preference for a M.S. in statistics or related field, at least three (3) years of experience in statistical analyses.

2.7 Deliverables

2.7.1 The Contractor shall electronically submit a monthly Progress Report to the COR by the 10th of each month documenting the progress of the study(ies), noting all technical areas where effort is being directed and indicating the status of work within each specified task. Information shall include, but not be limited to, current status, collection efforts, preliminary data analysis, and adverse and unexpected effects. This information may be submitted with each individual task order or may be consolidated into one report.

2.7.2 Initial findings may be submitted via e-mail to the COR. Final findings, once confirmed, shall be delivered to the address below:

U.S. Food and Drug Administration

ATTN: (To Be Determined at the Award of the Contract)

5100 Paint Branch Parkway

College Park, Maryland 20740

2.7.3 The contractor shall prepare an end-of-year report within 60 days of the current contract year expiration that summarizes the analytical results for the current contract year. The summary shall include, but not limited to, a summary of all sites and samples collected at each site; gps coordinates and photos of the sample sites; complete data analysis including all microorganisms tested for and enumeration, if appropriate; copies all data sheets; any technical barriers. The exact form of this summary shall be developed in consultation with the COR.

2.7.4. Other deliverables and deliverable schedules may vary by task and are to be determined upon issuance of individual task orders. All deliverables shall be delivered electronically and/or F.O.B Destination to the COR for acceptance.

The following are examples of deliverables:

· The Contractor shall submit all data generated from analysis of XXXX Environmental Samples related to important agricultural environments as outlined in each task order to the COR.

· Data shall include all of the test data including the location (country, state, town or city), type of environmental sample, the geographical location (GPS coordinates), collection date, and the date on which microbiological analysis was initiated. All data sheets for each microbiological analysis shall be provided to the COR organized in appropriately bound notebooks or as directed by the COR. Additionally, results from all of the test data shall be provided in the form of a single Excel spreadsheet.

· The contractor shall send all pathogenic isolates to the COR, including, but not limited to Salmonella, L. monocytogenes, E. coli 0157:H7, and non-O157:H7 STECs, Vibrio, Norovirus and Hepatitis A. The COR shall be notified of presumptive-positive results for any of the above pathogens as they become available. Once the contractor has isolated and confirmed any of the above pathogens, the contractor shall report the findings to the COR and provide the COR with all of the Contractors analytical worksheets. These analytical worksheets shall include, but are not limited to, chain of custody worksheets; data output worksheets; media/equipment quality control/quality assurance worksheets; and pictures of the environment from which the sample was collected. The contractor shall send isolates to the COR as soon as possible after confirmation. The COR shall also be provided with shipping information as to when the isolate(s) will be sent. No such isolate should be destroyed without the COR's written permission.

2.8 Period of Performance

The period of performance for this contract vehicle shall be the effective date of contract for a base year of 12 months and four (4) option years.

3 - CONTRACT ADMINISTRATION DATA

3.1 Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (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; and (5) assisting in the resolution of technical problems encountered during performance.

3.2 Contracting Officer (CO)

The Contracting Officer is the only person with 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 a task order; (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 contact information for the Contracting Officer is:

Gina Jackson Gina.Jackson@fda.hhs.gov

Tel: (301)827-1982; Fax: (301) 827-7101 The contact information for the Contract Specialist is:

Tomeka Evans

5630 Fishers Lane

Rockville, MD 20852

Tomeka.Evans@fda.hhs.gov

Tel: (301) 827-7168; Fax: (301) 827-7101 The contact information for the Ombudsman is:

Ronald Rouse

Ronald.Rouse@fda.hhs.gov Tel: (301) 827-7042; Fax: (301) 827-7106

SECTION 4 - CONTRACT CLAUSES

4.1 Addendum to FAR Clause 52.212-4 –Contract Terms and Conditions -- Commercial Items (Jul 2013)

4.1.2 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 address(es): www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

4.1.3 Ordering

4.1.3.1 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 award through the life of the contract.

(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.

4.1.3.2 Ordering Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Office.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and Deliverables

5. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order

b) Requests for Task Order Proposals (RFTOPs) shall only be issued to Contractor(s) by the Contracting Office and may be submitted via mail, e-mail or fax. In the case of multiple awards, task orders will be competed amongst all Contractor(s) unless an order is placed to meet a minimum guarantee.

c) The Contractor(s) shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor(s) shall submit the task proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. The Contractor(s) shall provide a breakdown of other direct costs, if applicable. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

The Government will evaluate task order proposals for technical acceptability and price reasonableness. FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the materials and/or level of effort are sufficient. If the FDA has questions or concerns the Contracting Officer may contact the contractor, and may ask for a revised proposal. Once the proposal is acceptable, the Contracting Office will issue the task order.

4.1.4 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 of less than $1,000, 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 $1,800,000

(2) Any order for a combination of items in excess of $8,000,000; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (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 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.

4.1.5 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 contract expiration.

4.1.6 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 any time prior to contract expiration.

4.1.7 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 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 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 five (5) years.

4.1.8 FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (DEVIATION) (AUG 2012)

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012.

Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.

Include the substance of this clause, including this paragraph (b), in all subcontracts with small business concerns.

The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

4.1.9 HHSAR 352.242-70 Key Personnel (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The Key Personnel under this Contract are:

Senior Scientist – must possess extensive scientific experience in food and environmental testing and regularly performs high volume microbiological testing on foods and environmental samples.

Project Manager- must possess management and/or leadership experience in a food and environmental testing company that regularly performs high volume microbiological testing on food and environmental sampling.

Scientist- must possess scientific knowledge of food and environmental testing and regularly performs high volume microbiological testing on food and environmental samples.

4.1.10 Packaging and Marking

All deliverables under this contract shall be packed and marked in accordance with best commercial practices to ensure safe and timely delivery. Items shipped to the FDA shall be marked as follows:

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: Food and Drug Administration

10903 New Hampshire

WO32 RM3230 HFP-60

Silver Spring, MD 20993

Mark for: TBD

The Contractor shall mark each shipment with the company name, the contract number, the item identification, quantity of items, and notice of partial or final delivery.

4.1.11 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.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

4.1.12 508 Standard Requirements

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm The contractor is expected to use the existing FDA environment and tools which are already in compliance with 508 standard requirements.

4.1.13 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 of the Government.

All data associated with this project is the property of the FDA and may not be shared with any third party without expressed written consent of the CO or COR. 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.

4.1.14 Travel and Per Diem

Travel and Per Diem authorized under this contract shall be reimbursed in accordance with the Federal Travel Regulations currently in effect or, in the case of Foreign travel, the Standardized Regulations (Government Civilians, Foreign Areas), Section 925, "Maximum Travel Per Diem Allowances for Foreign Areas," prescribed by the Department of State, for travel in areas not covered in by the Federal Travel Regulations. Per Diem rates shall not exceed the Government approved rates in effect (http://www.gsa.gov/portal/category/21287).

Travel requirements under this contract shall be met using the most economical form of transportation available. If economy class transportation is not available, the request for payment voucher must be submitted with justification for use of higher class travel indicating dates, times, and flight numbers. All travel shall be scheduled sufficiently in advance to take advantage of offered discount rates, unless otherwise directed by the Contracting Officer.

Travel and Per Diem is applicable only to Contractors not within the local commuting area (50 miles). It is anticipated that any Contractors within the 50 mile commuting area will not propose travel costs for Task Orders. All travel Costs will be paid based on actual costs in accordance with the Federal Travel Regulation or Standardized Regulations. The contractor shall submit all travel receipts for with their invoice(s).

4.1.15 Invoice Submission

A. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration

Office of Acquisition and Grants Services

ATTN: Tomeka Evans, Contracting Specialist

5630 Fishers Lane

Room 2141, HFA-500

Rockville, MD 20852

Email: Tomeka.Evans@fda.hhs.gov ****Acceptable methods of delivery include: mail, hand delivery and email*****

(II) One copy to the Contracting Officer’s Representative (COR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration

ATTN: (To be determined upon contract award); COR

Address:

Email: XXXXX@fda.hhs.gov *****Acceptable methods of delivery include: mail, hand delivery and email*****

B. 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 applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

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

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

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject award, including the following: 1) Invoice number, Amount and Date Submitted; 2) Corresponding payment amount and date received.

(b) Total amount of all payments received to date under the subject contract or order.

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current active period of performance.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Office of Financial Services Food and Drug Administration W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue

Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002

Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov Payment will be made on a task order basis and will occur upon verification by FDA COR.

(End of Addendum to FAR 52.212-4)

4.2 FAR 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Aug 2013)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

_X_ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

_X_ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

_X_ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

___ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (11) [Reserved]

_X_ (12) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (13) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (14) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)).

___ (15) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (July 2010) of 52.219-9.

_X_ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

_X_ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

___ (18) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (19) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

___ (ii) Alternate I (June 2003) of 52.219-23.

___ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (21) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

_X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_X_ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

_X_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (34) 52.222-54, Employment Eligibility Verification (Jul 2012). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated…