FINAL _15-223-SOL-00018.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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OFFEROR

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X

X

541380

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OR

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

04/14/2015 1600 ET240-402-7568NICOLA CARMICHAEL

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INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

15-223-SOL-00018

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 53 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$15.0

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

PATH Study Analysis: Assays of Multiple Analytes

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDEND

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

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25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

15-223-SOL-00018

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SECTION 1 – SUPPLIES AND SERVICES AND PRICES

1.1 SOLICITATION DESCRIPTION

The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has a need for non-personal, professional scientific laboratory services for the Population Assessment of Tobacco and Health (PATH) study. The Contractor shall furnish all necessary facilities, materials, and personnel and shall perform non-personal professional services and program support to complete all tasks and deliverables for this requirement entitled, “PATH Study Analysis: Assays of Multiple Analytes.”

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and an additional solicitation will not be issued.

This solicitation is a Request for Proposal (RFP) under FAR Part 12, Acquisition of Commercial Items, and Part 15, Contracting by Negotiation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-80. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541380, Testing Laboratories, which has an associated Small Business Size Standard of $15 million. This is a TOTAL SMALL

BUSINESS SET-ASIDE.

1.2 CONTRACT TYPE

This is a firm-fixed-price requirement. The period of performance is a one year base period with four one year option periods.

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1.3 PRICING

Firm-Fixed-Prices:

Base Year:

Contract Line Item Number

(CLIN)

Tasks and Deliverables Total Firm- Fixed- Price

0001 Kickoff Meeting Notes Testing, Analysis, and Reporting

Analyte, Sample Matrix, and FDA Proposed Methodology (Based on Duplicate or Triplicate Measurement)

Sample Unit Firm- Fixed- Price

Quantity

0002 Human Fibrinogen Activity, Plasma, and Clauss

5540 (Part 1: 40 Quality Control (QC) Pool Samples and Part 2: 5500 Participant Samples)

0003 Human Interleukin-6 (IL-6), Plasma, and Enzyme-Linked Immunosorbent Assay

(ELISA)

5540 (Part 1: 40 QC Pool Samples and

0004 Human Soluble Intercellular Adhesion Molecule (sICAM), Plasma, and ELISA

5540 (Part 1: 40 QC Pool Samples and

0005 Final Report Total Base Period Firm-Fixed-Price

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Option Year 1:

CLIN Tasks and Deliverables Total

Firm- Fixed- Price

1001 Kickoff Meeting Notes Testing, Analysis, and Reporting

Analyte, Sample Matrix, and FDA Proposed Methodology (Based on Duplicate or Triplicate Measurement)

Sample Unit Firm- Fixed- Price

Quantity

1002 Optional Task 1: Human Fibrinogen Activity, Plasma, and Clauss

5540 (Part 1: 40 QC Pool Samples and

1003 Optional Task 2: Human IL-6, Plasma, and ELISA

5540 (Part 1: 40 QC Pool Samples and

1004 Optional Task 3: Human sICAM, Plasma, and

ELISA

5540 (Part 1: 40 QC Pool Samples and

1005 Final Report Total Option Year 1 Firm-Fixed-Price

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Option Year 2:

Firm- Fixed- Price

2001 Kickoff Meeting Notes Testing, Analysis, and Reporting

Analyte, Sample Matrix, and FDA Proposed Methodology (Based on Duplicate or Triplicate Measurement)

Sample Unit Firm- Fixed- Price

Quantity

2002 Optional Task 4: Human Fibrinogen Activity, Plasma, and Clauss

5540 (Part 1: 40 QC Pool Samples and

2003 Optional Task 5: Human

5540 (Part 1: 40 QC Pool Samples and

2004 Optional Task 6: Human

ELISA

5540 (Part 1: 40 QC Pool Samples and

2005 Final Report Total Option Year 2 Firm-Fixed-Price

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Option Year 3:

Firm- Fixed- Price

3001 Kickoff Meeting Notes Testing, Analysis, and Reporting

Analyte, Sample Matrix, and FDA Proposed Methodology (Based on Duplicate or Triplicate Measurement)

Sample Unit Firm- Fixed- Price

Quantity

3002 Optional Task 7: Human Fibrinogen Activity, Plasma, and Clauss

5540 (Part 1: 40 QC Pool Samples and

3003 Optional Task 8: Human

5540 (Part 1: 40 QC Pool Samples and

3004 Optional Task 9: Human

ELISA

5540 (Part 1: 40 QC Pool Samples and

3005 Final Report Total Option Year 3 Firm-Fixed-Price

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Option Year 4:

Firm- Fixed- Price

4001 Kickoff Meeting Notes Testing, Analysis, and Reporting

Analyte, Sample Matrix, and FDA Proposed Methodology (Based on Duplicate or Triplicate Measurement)

Sample Unit Firm- Fixed- Price

Quantity

4002 Optional Task 10:

Human Fibrinogen Activity, Plasma, and Clauss

5540 (Part 1: 40 QC Pool Samples and

4003 Optional Task 11:

Human IL-6, Plasma, and ELISA

5540 (Part 1: 40 QC Pool Samples and

4004 Optional Task 12:

Human sICAM, Plasma, and ELISA

5540 (Part 1: 40 QC Pool Samples and

4005 Final Report Total Option Year 4 Firm-Fixed-Price

Grand Total Price (i.e. summation of the Base Year and Option Years 1, 2, 3, and 4’s total prices):________________________

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

CTP’s mission is to protect the public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco use, including understanding the harms and risks of the usage of tobacco products at both the individual and population level. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). The Tobacco Control Act granted FDA new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health, including to (1) prevent Americans, especially youth, from starting to use tobacco, (2) encourage current tobacco users to stop using tobacco, and (3) decrease the harms of tobacco product use.

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In support of these mandates, the CTP is partnering with the National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA) on a large-scale research collaboration, the “Population Assessment of Tobacco and Health” or PATH Study. This landmark effort is aimed at enhancing the evidence base available to FDA to inform the development and implementation of near- and long-term tobacco product regulations.

The PATH Study is a longitudinal, nationally representative study of tobacco use and health in the U.S. population. A cohort of approximately 46,000 adults and youth ages 12 years and older are followed annually for three years to assess use of existing and emerging tobacco products; attitudes and perceptions related to the use of different tobacco products; and near- and longer-term health outcomes associated with tobacco product use. The study includes the collection of biospecimens among adults 18 years of age and older to examine markers of tobacco exposure and tobacco-related disease processes. Urine and whole blood are collected and shipped to the PATH Study Repository for processing, aliquoting, and long-term storage.

2.2 OBJECTIVE

The objective of this contract is to support the FDA’s implementation of the Tobacco Control Act through providing non-personal, professional scientific laboratory services for the PATH study. The Contractor shall (1) characterize QC pools associated with each analyte, and (2) measure specific analytes in participant samples.

2.3 STATEMENT OF WORK

The Contractor shall perform the following tasks and provide the following deliverables.

The Contractor shall obtain all materials and supplies, unless otherwise indicated in the contract.

Facilities:

All work shall be performed off-site at the Contractor’s facilities. Throughout the period of performance of the contract, the Contractor’s facilities must be accredited by the College of American Pathologists or equivalent accreditation and participate in a Proficiency Testing program through independent laboratories, such as the College of American Pathologists or a comparable program. In addition, the Contractor’s facilities must hold active certifications in compliance with the Clinical Laboratories Improvement Act of 1967 (Public Law 90-174) and the Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578) throughout the period of performance of the contract. The Contractor shall provide the Contracting Officer’s Representative (COR) current facility accreditation and certification documentation on an annual basis.

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Human Subjects Protections

All work under this contract is subject to the Privacy Act, the Health Insurance Portability and Accountability Act (HIPAA), the FDA’s Research Involving Human Subjects Committee (RIHSC), and related laws, rules, policies, and procedures associated with the projection of human subjects and their information. The Contractor shall follow all relevant Privacy Act, HIPAA, and RIHSC rules and regulations. No samples shall contain personally identifiable information (PII) or protected health information (PHI).

The Contractor shall use barcode and human readable unique sample identification numbers so that no PII or PHI is used in this contract.

The Contractor shall provide the FDA information needed for RIHSC approval and compliance, such as information about its Project Director and Senior Scientist and its own human subjects policies and procedures.

(1) Kickoff Meeting:

The Contractor shall conduct a kickoff meeting with CTP via teleconference within 10 calendar days of the effective date of the contract. The Contractor shall discuss test procedures and conditions, including the use of specific sample analysis kits. The Contractor shall provide the COR with kickoff meeting notes within five calendar days of the kickoff meeting.

(2) Testing and Analysis:

The Contractor shall perform laboratory tests and analysis based on the following analyte, sample matrix, test methodology, and QC pool and participant sample combinations:

Analyte Measured Human Fibrinogen Activity

Human IL-6 Human sICAM

Sample Matrix Plasma Plasma Plasma

FDA’s Proposed Test Methodology

Clauss ELISA ELISA

Number of QC Pool Samples

40 40 40

Number of Participant Samples

5500 5500 5500

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Part 1: Characterization of QC Pools

The Contractor shall first test and characterize 40 QC samples in accordance with the analyte, sample matrix, and methodology combinations described above. The Contractor will receive 40 frozen QC specimen pool samples in batches from the PATH Study Repository in advance of participant samples for the Contractor to characterize. The Contractor shall make measurements in 20 successive analytical runs to obtain maximum among- and within-run variation to calculate the mean, standard deviation, and coefficient of variation (CV) for precision and accuracy estimates for the QC pool samples. If the Contractor determines a QC sample is outside of a three standard deviation range of results or more than one QC sample is outside of a two standard deviation range of results, the Contractor shall investigate and document the failure(s) and the cause(s) of the problem(s) that led to the unacceptable result(s) and rerun the sample in consultation with the COR.

The Contractor shall purchase or prepare reagents such that laboratory assays for characterization of QC samples are performed with the same lot number (or primary batch) of reagents. All operational QC testing shall be performed using the same lots of reagents throughout testing. Upon the Contractor’s characterization of the QC samples, the PATH Study Repository will seed QC pool samples into subsequent participant sample test batches as blind QC samples.

Part 2: Analyte Analysis of Participant Samples

The Contractor shall measure each of the three analytes in duplicate or triplicate depending on the assay from 5500 participant samples. The Contractor shall characterize specimens collected from participants in the PATH Study using the analyte, sample matrix, and methodology combinations described above. The Contractor will receive batched frozen study participant samples from the PATH Study Repository for the Contractor to characterize. The PATH Study Repository will seed blind QC samples into each rack of study participant specimens as a method of internal quality assessment for study operations.

Test Procedures and Conditions:

• The PATH Study Repository will send samples that been aliquoted in specified volumes and frozen in cryovials to the Contractor in batches for testing. The PATH Study Repository will send samples to the Contractor with a two-dimensional barcode and human readable unique sample identification number labels, which will not contain PII or PHI. The Contractor shall confirm receipt of the samples.

• The Contractor shall execute a material transfer agreement with NIDA for the transfer of samples (see https://ttc.nci.nih.gov/forms/mta.php).

• The Contractor shall provide and use an electronic tracking systems, which shall include the following:

Page - 11 - of 53 o Account for the receipt of samples from the PATH Study Repository, including identification of individual samples, date of sample receipt, and an analysis code for each analyte ordered on each sample. The Contractor shall confirm with the COR when and what samples it receives, tests to be performed, and any problems with samples, including any discrepancies between submitted and received information from the PATH Study Repository, within 24 hours of the Contractor’s receipt of the samples.

o Track samples in the testing and analysis process, including the ability to read two-dimensional barcodes.

o Convey analysis results in a data exchange format and enable the transfer of electronic test results to the COR. The Contractor shall provide the following information for each sample to the COR: identify its batch, date of analysis, analyst, and instrument.

o Display data clearly showing retests of abnormal or out-of-range results and final results with an appropriate comment code, indicating such abnormality or out-of-range result.

o Permit the COR to inspect quality control data, including internal laboratory quality control results, upon the COR’s request.

o Retain detailed information needed for an audit, such as the date, time, and technician identification for testing and analysis actions.

• The Contractor shall maintain adequate storage facilities, which includes vapor-phase liquid nitrogen [VPLN, -130 to -150 ºC] or a -70 to - 80 ºC mechanical freezer, for samples upon receipt of them, including any excess samples remaining in vials after analysis.

• The Contractor shall thaw rapidly (i.e. within 2 to 4 minutes) plasma specimens at 37 ºC in a water bath only if laboratory measures are planned within 24 hours of thawing the sample. While awaiting analysis, the Contractor shall store thawed specimens at 4 to 8 ºC.

• The Contractor shall maximize batch sizes to minimize the amount of time (or number of batches) over which samples are analyzed for a particular assay.

• The Contractor shall process aliquots received in FluidX cryovial tubes that have been in -80°C storage at the PATH Study Repository.

• The Contractor shall provide assay components with the longest date to expiration and anytime the Contractor purchases a new lot of assay material, the Contractor shall test batch controls to ensure lots produce accurate results and assays are functioning properly.

• The Contractor shall apply Westgard rules, if applicable, to quality control aspects of test methods.

• The Contractor shall retain samples for up to one month after receipt of them and send back to the PATH Study Repository any unused samples, as determined by the COR. The Contractor shall anticipate sending back about 10 percent of the samples to the PATH Study Repository.

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Technical Changes:

The Contractor shall provide advance written notice to the COR of any proposed technical changes to methodologies, reference ranges, reagents, or other procedures. No technical changes will be permitted unless written approval is received in advance from the COR. No contractual changes may be made without written approval by a duly authorized FDA Contracting Officer.

Reporting Requirements:

• Batch Reports:

o The Contractor shall complete testing and analysis of a batch of samples within 30 calendar days after receipt of the batch. The Contractor shall send the COR a batch report for each batch of samples no later than 10 calendar days from completion of laboratory testing and analysis for the particular batch. The Contractor shall include the following in each batch report:

For each sample, including the following:

• PATH Study sample identification number

• Date and time accessioned by the Contractor’s laboratory

• Identification of laboratory that performs the testing

• Test methodology and instrument utilized

• Date of analysis and analyst who performed the analysis

• Test result value with appropriate units

• Reference range, if applicable

The Contractor shall document a between-run, among-run CVs for performed measurements. The CVs shall be within generally acceptable ranges for laboratory assays.

• Problem Resolution Log:

o The Contractor shall provide on-going quality surveillance and monitoring of results. The Contractor shall maintain a cumulative, detailed account of problems and their resolutions, including the date and description of the problems and date and nature of the resolutions, as well as personnel that developed the resolutions, throughout the period of performance of the contract. The Contractor shall account for a full range of potential problems, such as not following protocols, failed quality control results and their significance, failed blind quality control results, batch inconsistency, delays in results, and changes in quality that may affect outcomes. If the Contractor determines a QC sample is outside of a three standard deviation range of results or more than one QC sample is outside of a two standard deviation range of results, the Contractor shall investigate and document the failure(s) and the cause(s) of the problem(s) that led to the unacceptable result(s), which shall include:

How the problem was investigated, including a written summary of the steps the Contractor took to determine the nature of the problem(s).

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Findings as to the cause(s) of the unacceptable result(s). If an error is determined to be a technical or methodological error, the Contractor shall submit to the COR all quality control data from the batch of samples which included the incorrect result.

Specific corrective action (the changes implemented) taken to prevent recurrence of the problem(s).

Evidence, including actions taken, that the problem(s) was successfully corrected.

Evidence the top official in charge of the laboratory reviewed the investigation and approved its methods, findings, and corrective actions.

The Contractor shall provide interim problem resolution logs to the COR every three months and a final problem resolution log with the final report.

• Final Report:

The Contractor shall provide a final report, which shall include the following:

o Summary of methods, data, analysis, and major findings of all tests completed.

o Account of total assays completed by sample identification number.

o Final problem resolution log, which shall include a summary of all problems and resolutions.

• Non-reporting Communication:

o Biweekly Conference Calls: The Contractor shall conduct conference calls with the COR and her colleagues every two weeks when the Contractor is conducting testing to track the progress of analyses, results, and to discuss any real or potential problems. Within two business days after each teleconference, the Contractor shall provide the COR with meeting notes, including a summary of discussions, action items, and due dates for the action items.

o Notice to the COR of Problems: The Contractor shall notify the COR in writing immediately of any current or foreseeable problems with any of the tasks or deliverables, including preparatory testing activities and data collection.

Deliverable Schedule:

The Contractor shall complete and deliver the above stated deliverables according to the following schedule:

Deliverable Due Date

Kickoff Meeting Notes

Five calendar days from the kickoff meeting

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Biweekly Conference Call Meeting Notes

Two business days after each teleconference

Batch Reports 10 calendar days from completion of laboratory testing and analysis for a particular batch of samples

Interim Problem Resolution Logs Every three months

Monthly Progress Reports (see Subsection 6.2 below)

10th day of each month

Final Report and Final Problem Resolution Log

Three months after the final sample is assayed

2.4 KEY CONTRACTOR PERSONNEL

The above named individuals are designated as key personnel for this contract and are considered essential for its successful performance. In the event any of the key personnel are unable to perform as proposed for any reason during the performance of the contract, the Contractor shall immediately notify the COR and Contracting Officer in writing.

Such notice shall include an explanation for lack of performance, a proposed replacement by someone of equal or better qualifications and experience, and shall explain the impact on performance. The Contractor shall provide the Contracting Officer and the COR the same personnel information (e.g. resumes) for replacement personnel as the Contractor provided for the initial personnel. Replacement personnel shall have at least the same or equivalent knowledge, skills, and abilities that are necessary to complete the work on this contract as the original assigned personnel. All replacements are subject to the prior approval of the Contracting Officer.

The following labor categories are considered key: Project Director and Senior Scientist.

Project Director: The Project Director shall have advanced knowledge of the relevant science and the ability to apply new and unique methods and procedures to meet the FDA’s requirements. The Project Director shall have significant recent and relevant experience working on projects of similar size and scope to this procurement.

Senior Scientist: The Senior Scientist shall serve as a principal investigator and lead person for protocol development and requirement completion. The Senior Scientist shall provide technical and subject matter expertise. The Senior Scientist shall have significant recent and relevant experience working on projects of similar size and scope to this procurement.

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SECTION 3 - 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.

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: U.S. Food and Drug Administration offices located in the Washington, DC metropolitan area

Mark for: TBD

The Contractor shall mark each shipment with their name, contract number, identification of the item(s), quantity of items, and notice of partial or final delivery. For electronic deliverables, the Contractor shall identify the title of the document and contract number in the subject line of the email.

SECTION 4 - INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance and completion decisions for all tasks and deliverables provided under this contract.

For the purpose of this Section, the FDA COR is the authorized representative of the Contracting Officer.

SECTION 5 - DELIVERIES OR PERFORMANCE

See 2.3, Statement of Work, for detailed deliverable information. All deliverables shall be delivered F.O.B. Destination to the COR for acceptance.

FAR 52.252-2, Clauses Incorporated by Reference (February 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:

www.acquisition.gov/far/index.html.

FAR 52.247-34, F.O.B. DESTINATION (NOV 1991)

ELECTRONIC SUBMISSION:

The Contractor shall submit all required text deliverables electronically in Microsoft Word 2010 compatible format with 12 point font to the COR. The Contractor shall submit all data to the COR in a format and method determined by the COR. The Contractor shall confirm all http://www.acquisition.gov/far/index.html

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PUBLICATIONS AND PRESENTATIONS:

The Contractor shall not present, publish, or otherwise release any information arising out of their contract without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions.

RIGHTS IN DATA AND REPORTS:

Property rights, including data first produced under this contract, source code, and publication rights, arising out of this contract shall rest with the Government and the Contractor, in accordance with FAR 52.227-14, Rights in Data - General (MAY 2014), Alternate V (DEC 2007), and FAR 52.227-16, Additional Data Requirements (JUN 1987).

5.1 PERIOD OF PERFORMANCE

The contract’s period of performance is one year from the effective date of the contract with four one year option periods.

5.2 OPTIONS

The FDA has a unilateral right to exercise one, two, or all three test options per option year for a total of 12 options over four option years. Each option is an analyte category (Human Fibrinogen Activity, Human IL-6, or Human sICAM). The Contractor shall perform option tasks and deliverables under the same terms and conditions agreed to in the base period.

The optional periods of performance, if exercised, are as follows:

OPTION

YEAR

PERIOD FROM THE EFFECTIVE DATE OF THE

CONTRACT

Option Year 1 One Year (approximately May 15, 2016 to May 14, 2017) Option Year 2 Two Years (approximately May 15, 2017 to May 14, 2018) Option Year 3 Three Years (approximately May 15, 2018 to May 14, 2019) Option Year 4 Four Years (approximately May 15, 2019 to May 14, 2020)

FAR 52.217-9, Option to Extend the Term of the Contract (March 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the

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Government gives the Contractor a preliminary written notice of its intent to extend at least 30 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 years and six months.

(End of clause)

FAR 52.217-8, Option to Extend Services (November 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 the period of performance of this contract.

(End of Clause)

SECTION 6 - CONTRACT ADMINISTRATION

6.1 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

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

The COR is responsible for the following: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the FDA Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

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 direct or negotiate any changes to the contract, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of their contract.

The contact information for the FDA Contracting Officer is the following:

James N. Chestnut U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

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5630 Fishers Lane Rockville, MD 20857 James.Chestnut@fda.hhs.gov

Telephone: (240) 402-7570

The contact information for the FDA Contract Specialist is the following:

Nicola L. Carmichael

Office of Acquisitions and Grants Services

5630 Fishers Lane Rockville, MD 20857 Nicola.Carmichael@fda.hhs.gov Telephone: (240) 402-7568

6.2 MONTHLY PROGRESS REPORTS

The Contractor shall submit monthly progress reports via email to the COR and the Contract Specialist with each monthly invoice or by itself, if no invoice is submitted for a particular month, no later than by the 10th day of each month. Each progress report shall contain concise statements covering the activities relevant to the contract, including:

(a) A clear account of the work performed during the reporting period;

(b) An outline of the work to be accomplished during the next reporting period; and

(c) A description of any problems encountered or anticipated that will affect the completion of any work within the agreed upon time and fiscal constraints, together with recommended solution(s) to such problem(s); or, a statement that no problems were encountered.

The monthly progress reports do not eliminate any of the other reporting requirements or deliverables in the contract.

6.3 PAYMENT

Payment is only authorized upon successful completion of the tasks and deliverables described in Section 2 above and the FDA’s acceptance of a proper invoice. Proper invoice submission includes following the invoice instructions herein (see Subsection 6.4, Invoice Submission).

The FDA will only pay the Contractor upon completion of the respective deliverables stated in Subsection 1.3, Pricing (i.e. kickoff meeting notes; sample testing, analysis, and reporting; and the final report), at the firm-fixed-prices delineated in Subsection 1.3. The Contractor may invoice no more frequently than monthly.

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The Contractor’s sample unit firm-fixed-prices are inclusive of all direct and indirect costs and profit per sample for complete testing, analysis, and reporting (except the final report), including all facilities, materials, and labor, receipt and storage of the sample, and return of any unused samples to the PATH Study Repository. The Contractor may only invoice the sample firm-fixed-prices upon completion of all tasks and deliverables associated with the sample, including all testing, analysis, batch reporting, receipt and storage of the sample, and return of unused samples to the PATH Study Repository.

6.4 INVOICE SUBMISSION

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) One original to the Contract Specialist:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Nicola L. Carmichael, Contract Specialist 5630 Fishers Lane

HFA-500

Rockville, MD 20857

Nicola.Carmichael@fda.hhs.gov

(II) One copy to the COR clearly marked as a “Courtesy Copy Only:”

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

Email: XXXXX@fda.hhs.gov

Acceptable methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein.

The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on Contractor letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Contract number;

(IV) Description, quantity, unit of measure, unit price, and extended price for supplies mailto:XXXXX@fda.hhs.gov

Page - 20 - of 53 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 contract or in a proper notice of assignment);

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

(IX) Dun and Bradstreet (DUNS) and Taxpayer Identification Numbers (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 COR; and (XII) Any other information or documentation required by the contract.

The Contractor shall 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 contract, including the following:

(1) invoice number, amount, and date submitted to the Contract Specialist; and (2) corresponding payment amount and date received payment.

(b) Total estimated amounts yet to be invoiced under the contract.

D. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

Office of Financial Services

10903 New Hampshire Avenue W032, Second Floor Mail Hub 2145 Building 32, Room 2162 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

7.1 CONTRACTOR PERFORMANCE EVALUATIONS

In accordance with FAR 42.15, FDA will complete annual and final Contractor performance evaluations. Annual evaluations will be prepared to coincide with the

Page - 21 - of 53 anniversary date of the contract. Additional interim performance evaluations may be prepared at the FDA’s Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon expiration of the contract.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at the following address: https://cpars.cpars.gov/. FDA will register the Contractor in CPARS upon receipt of the names and email addresses of two 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 identification information and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contacts will receive an email instructing them to access CPARS to review the performance evaluation. The Contractor has 14 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, the Contractor shall submit rebuttal comments via CPARS within 14 days from the date the evaluation was issued by the 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 three year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

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

7.2 SECTION 508 STANDARD REQUIREMENTS

The Contractor shall ensure all deliverables are in compliance with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended (508 standards), which requires electronic and information technology (EIT) to be accessible to people with disabilities.

Information about Section 508 compliance is available at http://www.section508.gov/.

7.3 SECURITY AND PRIVACY

To ensure adequate security and privacy protections, the Contractor shall follow the following terms (see also PUBLICATIONS AND PRESENTATIONS found in Section 5). Unless otherwise indicated below, the Contractor shall submit all security and privacy forms and other documentation to the COR or her designee for review and approval.

http://www.ppirs.gov/ http://www.section508.gov/

Page - 22 - of 53

• 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.

• Except as may otherwise be permitted by a data owner, Contractor personnel agree not to use, disclose, or reproduce proprietary data, other than as required in performance of the contract; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the Contractor without such limitation.

• Each Contractor or subcontractor personnel who may have access to non-public U.S. Department of Health and Human Services (HHS) information under this contract shall complete and submit a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement. A copy of each signed and witnessed 3398 form shall be submitted to the COR or his or her designee prior to performing any work under this contract. The Contractor shall hold all discussions and deliberations under their contract as confidential and shall limit public access and distribution of the work resulting from their contract. The Contractor shall secure facilities and communications to limit the access and distribution of any materials, documents, data, findings, analysis, or conclusions arising out of their contract. The Contractor agree Contractor personnel shall not divulge or release data or other information developed or obtained in connection with the performance of their contract to anyone, unless made publically available by the FDA or upon written approval of the COR or his or her designee.

• The U.S. Department of Health and Human Services (HHS) policies require contractors, including subcontractors, receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The Contractor shall ensure that all of its personnel and subcontractor personnel anticipated to work under this contract have completed all requisite training.

• To ensure compliance with Federal laws, rules, procedures, policies, and regulations related to privacy and security, the COR or his or her designee may require other forms or training for Contractor personnel before or during their performance under their contract.

7.4 CONFLICTS OF INTEREST

Each offeror shall warrant that, to the best of its knowledge and belief, and except as otherwise disclosed in its proposal, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject procurement, as described in FAR Subpart 9.5, for its organization, employees, or subcontractors proposed to be working under procurement.

Each offeror shall agree that, if it is awarded a contract for this procurement and

Page - 23 - of 53 discovers an actual, potential, or apparent conflict of interest with respect to this procurement after executing its contract, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer and COR for this contract, including a description of any actions the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any conflict of interest. The Contractor shall act impartially and objectively and must avoid actions that would cause a reasonable person to question their impartiality or engage in activities that may result in an unfair competitive advantage, such as:

1. Giving preferential treatment to any individual or organization which has submitted applications, information, or data;

2. Soliciting any gift or other item or accepting any gift or other item of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with, or conducting activities related to the evaluations and work performed under this contract. The Contractor shall not accept individual gifts with an aggregate market value of greater than $50.00 in a calendar year.

3. Disclosing non-public information unless otherwise authorized (see also PUBLICATIONS AND PRESENTATIONS in Section 5, and Subsection 7.3, SECURITY AND PRIVACY).

4. Participating in matters involving parties who are likely to or can directly affect the financial interest of people in the Contractor personnel’s households or relatives of Contractor personnel with whom they have a close personal relationship.

5. Not disqualifying themselves from participating in matters involving former Contractor employees who were Contractor employees within the past three years or former Contractor employee representatives who might represent a conflict of interest.

The Government reserves the right to exercise any remedy available at law or equity, including termination of a contract for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.

The Contractor shall include a clause substantially similar to this conflicts of interest clause in any subcontract.

Page - 24 - of 53

SECTION 8 - CONTRACT CLAUSES

8.1 FAR 52.252-2, Clauses Incorporated by Reference (February 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:

www.acquisition.gov/far/index.html.

52.212-4, CONTRACT TERMS AND CONDITIONS—COMERCIAL ITEMS

(DEC 2014)

52.227-14, RIGHTS IN DATA - GENERAL (MAY 2014), ALTERNATE V (DEC

2007)

52.227-16, ADDITIONAL DATA REQUIREMENTS (JUN 1987)

52.232-40, PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

52.242-15, STOP-WORK ORDER (AUG 1989)

52.242-17, GOVERNMENT DELAY OF WORK (APR 1984)

8.2 FAR CLAUSE BY FULL TEXT

FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS

(MAR 2015)

(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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(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) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(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:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

http://www.acquisition.gov/far/index.html

Page - 25 - of 53

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509).

___ (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) [Reserved] _X_ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111- 117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__X_ (8) 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__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

____ (ii) Alternate I (Nov 2011) of 52.219-3 ___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

____ (ii) Alternate I (Jan 2011) of 52.219-4 ___ (13) [Reserved] _X_ (14) (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).

___ (15) (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__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C.

637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (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 (Oct 2014) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

_X_ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657f).

Page - 26 - of 53

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women- Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 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_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X__ (26) 52.222-19, Child Labor—Cooperation with…