FDA-RFQ-1115032_REV.pdf

Solicitation Number: FDA-RFQ-1115032

PART 1 – Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERICAL ITEMS

PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6 –

STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR

COMMERICAL ITEMS - AS SUPPLEMENTED WITH ADDITIONAL INFORMATION

INCLUDED IN THIS NOTICE. THIS ANNOUNCMENT CONSTITUTES THE ONLY

SOLICITATION: QUOTES ARE BEING REQUESTED, AND A WRITTEN SOLICITATION

DOCUMENT WILL NOT BE ISSUED.

This solicitation is a Request for Quotes (RFQ) using FAR Part 12 & 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-66.

This is a Full and Open solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 541711. Its associated Small Business size standard is 500 Employees.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

2.1. DESCRIPTION OF SUPPLIES & SERVICES

The primary function of the Food and Drug Administration ("FDA" hereinafter) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products ("CTP" hereinafter) implements PL 111-31 and H.R. 1256, Family Smoking Prevention and Tobacco Control Act that was signed into law on June 22, 2009. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health. Because tobacco products are not regulated as drugs, their effects on behavior and pharmacology have not been evaluated by FDA. The Contractor will provide the scientific support necessary to assist in the implementation of this law under the Federal Food, Drug, and Cosmetic Act.

Specifically, under this contract, the contractor will assist FDA by assessing tobacco product and tobacco product constituent pharmacology and dependence behaviors using nonclinical models.

2.2. Contract Type

This is an Indefinite Delivery Indefinite Quantity (IDIQ) type contract with a Five (5) year ordering period. The FDA has chosen to pursue an IDIQ contract to reduce lead time to award task orders and to maximize the flexibility of selecting contract types appropriate to the specific tasks under consideration. At the discretion of the Contracting Officer, the government may use a Time and Materials, Labor-Hour, Firm Fixed Price or a combination thereof for the task orders.

Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government's determination of contract type.

2.3. Contract Ceiling

The IDIQ guaranteed minimum amount shall be $1,000.00 over five years. The maximum contract ceiling amount is $3Million. The maximum aggregate dollar value of all task orders shall not exceed the established agreement ceiling.

2.4. Pricing Terms

The unit prices specified in labor hour task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the task order. However, in no event shall the Contractor perform, or be paid for any work which exceeds the not-to exceed dollar amount of a task order.

2.5. Overview of Pricing Schedule

Fixed Price, Time and Materials and Labor Hour Tasks may be ordered via the issuance of individual Task Orders. The prices set forth below shall apply throughout the life of the agreement.

The contractor's pricing schedules for labor categories shall contain loaded hourly rates. The loaded hourly rates for each labor category shall be fully burdened to include wages, indirect costs (including local travel, fringe benefits, overhead, general and administrative, and profit.

Labor Categories Estimated

Hours per Year

Labor rates Base year

Labor rates Option Yr1

Labor rates Option Yr2

Labor rates Option Yr3

Labor rates Option Yr4

Senior Scientist 318 $ $ $ $ $ Project Director 343.5 $ $ $ $ $ Project Manager 479.1 $ $ $ $ $ Laboratory Technician 1661.5

Research Assistant 1661.5 $ $ $ $ $ Data Manager 504 $ $ $ $ $ Statistician 48 $ $ $ $ $ Subject Matter Expert 150

Writer/Editor 24 $ $ $ $ $

2.6. Material Handling

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

2.7. Provisions Applicable to Direct Cost

Notwithstanding Clause 52.216-7, Allowable Cost and Payment, and Clause 52.244-2, Subcontracts, of the Federal Acquisition Regulation (FAR), unless otherwise expressly provided elsewhere in the Contract or in any modification thereto, the cost of the following items or activities shall be unallowable as direct costs:

1. Acquisition by purchase or lease of any interest in real property;

2. Special rearrangement, certification or alteration of facilities;

3. Purchase, lease, or rental of any item of general purpose such as office furniture or equipment;

4. Travel to foreign countries;

5. Food and beverage costs unless part of per diem expenses paid in accordance with the Federal Travel Regulations.

PART 3 – STATEMENT OF WORK

3.1. Background

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act amended the Federal Food, Drug and Cosmetic Act (FD&C Act) by, among other things, adding a new chapter granting the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Section 906 of the Tobacco Control Act provides FDA with the authority to enter into contracts for research, testing, and demonstrations of tobacco products and to obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking a contractor to assess tobacco product constituents on pharmacology, reinforcement/reward, dependence, withdrawal and choice behaviors using nonclinical models.

3.2. Objective

The primary objective of this contract is to evaluate the impact of tobacco product constituents on pharmacology and behavior using nonclinical models. To fulfill these objectives, the Government seeks a contractor to perform a series of nonclinical studies with a wide range of tasks to accomplish the objectives as further described in the Statement of Work.

The range of tasks required for each task order will vary. These tasks shall include but not be limited to: providing input on scientific protocols and methodologies, providing animal subjects protection including Animal Care and Use Committee (ACUC) documentation and approval, providing documentation for FDA ACUC, administering the test constituent(s), collecting behavioral, pharmacological and toxicological data, performing data analyses, and creating scientific reports. Studies will assess the impacts of tobacco product constituents on pharmacological, toxicological and behavioral outputs, including histopathology and gross pathology, clinical chemistry and hematology, safety pharmacology endpoints for cardiovascular and respiratory systems, midbrain neurotransmitter release, reinforcement/reward, dependence, withdrawal, choice behavior, and physiological effects (e.g., peak plasma levels). Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco product constituents, and may guide tobacco product policies and regulations.

3.3. Scope of Work

Independently, and not as an agent of the Federal Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. Animal facilities where the work is to be performed must be AAALAC (http://www.aaalac.org/) certified at the time of contract award.

The Contractor shall provide support in accordance with the timelines stated in the deliverable schedule.

Contractor tasks shall vary and may include, but shall not be limited to:

Task#1: Pharmacological Assessments (in vitro, in vivo)

• Neurobiological assessments including dopamine release in the midbrain

• Toxicological assessments - histopathology and toxico/pharmacokinetics of tobacco constituents, cardiovascular and respiratory safety pharmacology parameters

Task#2: Behavioral Assessments in Rodents

• Motor activity using automated locomotor activity chambers

• Reinforcement assessments using self-administration (e.g. oral, intravenous)

• Reward assessments using automated place conditioning

• Dependence and withdrawal assessments including somatic withdrawal assessed through ratings of videotaped behaviors

• Choice behavior assessments

Task#3: Assess physiological measurements, including peak plasma levels of constituent(s).

Task#4: Prepare documentation for ACUC package submission

Task 5: Deliver tabulated interim raw data as well as the results of the data analyses in SAS transport (.xpt) format and a written report to the Government.

The Contractor’s activities shall depend on the individual Task Order requirement, which will define the specific needs of the Government and may include, but are not limited to, the following:

• Ordering, housing, handling and maintenance of cells and/or animals.

• Selecting the research facility to perform the study.

• Providing scientific expertise during the development of protocols and methodologies.

• Providing scientists and research assistants to execute laboratory protocols, including pharmacological and behavioral assessments.

• Monthly written reports documenting animal care (including issues related to animal care and use), progress on each activity of current task orders, interim data analysis (when scientifically feasable), and discussion of any problems or issues, including steps taken to resolve them and the results of those steps.

http://www.aaalac.org/)

• Providing comprehensive written minutes of all meetings and conference calls.

• Providing staff to perform quality assurance assessments.

• Analyzing pharmacological, toxicological and/or behavioral data, including measurement of plasma levels of constituent(s).

• Conducting scientific literature reviews.

• Providing the intermediate as well as final data reports, and working with the COR on scientific manuscripts for peer-reviewed journals.

PART 4 – Packaging and Marking

For electronic deliverables, the title of the document and contract number shall be identified in the subject line of the email.

PART 5 - INSPECTION AND ACCEPTANCE

a. The Contracting Officers Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided and performing the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the Contracting Officer and

COR.

b. For the purpose of this SECTION, the COR is designated as the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

FDA

Center for Tobacco Products Food and Drug Administration 9200 Corporate Blvd Rockville, MD 20850

Acceptance may be presumed unless otherwise indicated in writing by the COR.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

52.246-4, Inspection of Services-Fixed Price (Aug 1996) 52.246-6, INSPECTION-TIME AND MATERIAL AND LABOR HOUR (May 2001)

PART 6 – DELIVERIES OR PERFORMANCE

6.1. PERIOD OF PERFORMANCE

The period of performance for this contract shall be a base year and four additional option year periods.

6.2. DELIVERABLES

All reports required under this contract shall be typed (12 point font) and submitted electronically to the COR and the Contract Administrator in Microsoft Word 2007 compatible format. All tabulated data obtained from the studies shall be submitted in SAS transport (.xpt) format. All other reports and deliverables shall be specified on each task.

Deliverable Delivery Date Content of the Deliverable

Monthly Progress Reports per Task Order

The Contractor shall electronically submit to the COR by the 10th of each month for each thirty day period prior to the report due date.

Technical reports describing program progress to date, noting all technical areas where effort is being directed and indicating the status of work within each specified task.

Other task specific deliverables

As specified in the Individual Task Order.

As specified in the Individual Task Orders.

6.3. PLACE OF PERFORMANCE

All work will be performed at the Contractor and/or subcontractor’s facilities. All Facilities must be AAALAC certified (http://www.aaalac.org/). Written proof of AAALAC certification shall be provided as part of the proposal.

http://www.aaalac.org/).%20Written%20proof%20of%20AAALAC%20certification%20shall%20be%20provided%20as%20part%20of%20the%20proposal http://www.aaalac.org/).%20Written%20proof%20of%20AAALAC%20certification%20shall%20be%20provided%20as%20part%20of%20the%20proposal http://www.aaalac.org/).%20Written%20proof%20of%20AAALAC%20certification%20shall%20be%20provided%20as%20part%20of%20the%20proposal

PART 7 – CONTRACT ADMINISTRATION DATA

7.1. AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the performance of this Contract, the administration of this Contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government's points of contact during performance of the Contract:

7.2. CONTRACTING OFFICER/CONTRACT SPECIALIST/ADMINISTRATOR

The Contracting Officer for this Contract is (*To be completed at contract award).

can be reached at or electronically at @fda.hhs.gov. All communications pertaining to contractual and/or administrative matters under the Contract should be addressed to the Contract Specialist. The Contract Specialist assigned to this Contract is (*To be determined at contract award). All contract administration shall be performed by the Contract Specialist, (*To be determined at time of award), FDA/OC/OAGS, 5630 Fishers Lane, Rockville, Maryland 20857. (*To be determined at contract award) can be reached at

@fda.hhs.gov.

or electronically at

7.3. COR APPOINTMENT AND AUTHORITY

The COR assigned to this Contract is: TBD

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.

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 the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change its COR designation.

7.4. CONTRACTING OFFICER REPRESENTATIVE (COR) FOR TASK ORDERS

For each task order, a Task Order Contracting Officer Representative (COR) will be assigned.

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

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

The Government may unilaterally change its Contracting Officer Representation designation.

Technical Leads may assist the Contracting Officer Representative. The Technical Leads will not have the authority to provide technical direction in accordance with the paragraphs above;

however, they may be responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) reviewing of invoices/vouchers.

7.5. CONTRACT FINANCIAL REPORTING

For time and materials task orders, contactor must notify the CO and COR when 50% and 75% of the estimated budget has been expended. Financial reports shall be submitted monthly by the contractor with the invoices for time and materials and labor hour task orders in accordance with the 4 expenditure categories below:

1. Labor hours and total labor charges for each skill level category for the current period and cumulative cost for the total Task Order(s) to date.

2. Accumulated total for all cost categories (i.e., labor).

3. Task Order ceiling and percent expended to date.

4. Estimate to complete.

7.6. CONTRACTOR PERFORMANCE EVALUATIONS

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.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

http://www.cpars.csd.disa.mil/cparsmain.htm http://www.ppirs.gov/ http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm

7.7. SYSTEM FOR AWARD MANAGEMENT REGISTRATION

In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the -

Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS);

and the Catalog of Federal Domestic Assistance.

If a new Contractor, you will need only your personal information to create an account in SAM.

If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account.

(1) Definitions.

"Registered in the SAM database" means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor's CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

"System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations , or by the Government Accountability Office.

(2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM.

If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number-

(i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or

(ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office.

(3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206- 7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/

7.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

http://fedgov.dnb.com/webform https://www.acquisition.gov/ http://www.fsd.gov/ https://www.sam.gov/portal/public/SAM/

7.9. ORDERING PROCESSES AND PROCEDURES

7.9.1. Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. Consistent with FAR 16.505 (b)(1), the FDA will provide all awardees fair opportunity to compete for each task order.

7.9.2. Authorized Users. Only Food and Drug Administration, Office of Acquisitions & Grant Services Contracting Officers are authorized as ordering officials to place task orders under this contract. Any center anticipating placing task orders against this IDIQ shall submit a draft copy of their Statement of Work (SOW) to the COR for a “Scope Determination”. Once confirmed the SOW is within the scope of this IDIQ, the center will be granted written/verbal authorization by the Contracting Officer.

7.9.3. 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. A task order shall be "issued" for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work (SOW) in accordance with the technical requirements. 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.

b) Requests for Task Order Proposals (RFTOP) shall only be issued by the OAGS Contracting Officer.

c) The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit, or negotiate a task order proposal. The contractor shall re-self-certify their GLP statement for each task order proposal.

d) The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

e) The designated FDA Task Order Ombudsman is the FDA Head of Contracting Authority for the Office of Acquisition and Grant Services.

7.10. INVOICE SUBMISSION

2-Way Invoicing:

A. The contractor shall submit monthly 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: William Lee, Contracting Specialist

5630 Fishers Lane Room 2086, HFA-500 Rockville, MD 20852

Email: William.lee@fda.hhs.gov

****Acceptable methods of delivery include: mail, hand delivery and email*****

(II) One copy to the contracting officer technical 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 – Central Contractor Registration) 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;

mailto:William.lee@fda.hhs.gov mailto:XXXXX@fda.hhs.gov

(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 Technical Representative (COTR) 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@fd a.gov

7.10.1. Final payments will occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of each task.

7.10.2. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms.

mailto:fdavendorpaymentsteam@fda.gov mailto:fdavendorpaymentsteam@fda.gov

7.10.2.1. Payment will be made on a task order basis in accordance with the pricing matrix.

7.11. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

The Small Business Subcontracting Plan is attached hereto and made a part of this contract.

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR) Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Specialist shall be included as a contact for notification purposes at the following e-mail address:

William Lee Contract Specialist William.Lee@fda.hhs.gov

PART 8- SPECIAL CONTRACT REQUIREMENTS

8.1. ORGANIZATIONAL CONFLICT OF INTERESTS

The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

http://www.esrs.gov/

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

8.2. PUBLICATIONS AND STUDY PRESENTATIONS

The Contractor shall not present or publish any information obtained through this contract without the express or prior written consent of the COR.

8.3. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, request for proposals, bid solicitation and other documents describing projects or other programs funded in whole or in part by federal money: (1) the percentage of the total contract cost of the program or projects which will be financed with Federal money; (2) the dollar amount of federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

PART 9 – CONTRACT CLAUSES

9.1. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This Contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

FAR – http://www.acquisition.gov/far

52.227-14, Rights in Data-General (Dec 2007)

9.2. FAR CLAUSES IN FULL TEXT

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL ITEMS (JAN 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:

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).

(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 (June 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 (Aug 2012) (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).

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X (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

(7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313).

(8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 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).

X (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] (12)(i) 52.219-6, Notice of Total Small Business Set-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 (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

(15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (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 (Jul 2010) of 52.219-9.

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

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

(18) 52.219-16, Liquidated Damages—Subcon-tracting 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).

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

(20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged

Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

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(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. 657 f).

X (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C. 632(a)(2)).

(24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (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 (Apr 2012) (15 U.S.C. 637(m)).

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

(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).

(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 Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(36) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

(37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423).

(ii) Alternate I (DEC 2007) of 52.223-16.

X (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011) (E.O. 13513).

(39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

(40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act

(Nov 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1136380 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt09t12%2B37%2B408%2B%2B%2810%29%20%252 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_222.html#wp1147479 https://www.acquisition.gov/far/current/html/52_222.html#wp1147630 https://www.acquisition.gov/far/current/html/52_222.html#wp1147656 https://www.acquisition.gov/far/current/html/52_222.html#wp1147711 https://www.acquisition.gov/far/current/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt37t40%2B200%2B2%2B%2B%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_222.html#wp1148097 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt29t32%2B2%2B78%2B%2B%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_222.html#wp1148123 https://www.acquisition.gov/far/current/html/52_222.html#wp1160019 https://www.acquisition.gov/far/current/html/52_222.html#wp1156645 https://www.acquisition.gov/far/current/html/Subpart%2022_18.html#wp1089948 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168892 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168892 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt41t42%2B250%2B1286%2B%2B%2842%29%20%20AND%20%28%2842%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1178433 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_223_226.html#wp1179078 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1179078 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1188603 https://www.acquisition.gov/far/current/html/52_223_226.html#wp1168995 http://uscode.house.gov/ https://www.acquisition.gov/far/current/html/52_223_226.html#wp1169038 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt17t20%2B1727%2B50%2B%2B%2819%29%20%20AND%20%28%2819%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/ note, 19 U.S.C. 4001 note, Pub. L.