RFP_Final__FDA_RFP_1130639_Amendment_3.docx

Solicitation Number: FDA-RFP-1130639 – Amendment 3

PART I

SECTION 1 - SUPPLIES OR SERVICES AND PRICES/COSTS

1.1 SOLICITATION DESCRIPTION

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN 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 A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-80. The associated North American Industrial Classification System (NAICS) code for this procurement is 541611. The size standard is $15.0 , Administrative Management and General Management Consulting Services. This requirement is for full and open competition as a result of this combined synopsis/solicitation.

1.2 CONTRACT TYPE

The government intends to make award to no more than three (3) awardees as a multiple award, Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with the issuance of firm-fixed price, labor-hour and time and materials task orders.

1.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount will be $2,000.00 per awardee over five (5) years inclusive of options. The contract maximum ceiling amount will be $10,000,000.00 per awardee over five (5) years inclusive of options.

1.4 PRICING

The pricing chart below lists the labor categories that are anticipated to be required throughout the period of performance of the contract, inclusive of all option periods.

The Contractor shall provide services in accordance with the Statement of Work at fixed hourly rates.

Labor Rate Pricing Chart – Table #1 A (Government Site):

Labor Rate Pricing Chart – Table #1 B (Contractor Site):

_____ % Fee for Material Handling Fee Note: Contractor may add additional labor categories for additional personnel as necessary.

Note: Reference Section 2 for a full description of each labor category.

Note: Reference Section 2 for a full description of each labor category.

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

The mission of the FDA’s Center for Drug Evaluation and Research (CDER) is to assure that safe, effective, and high quality drugs are available to the American people. CDER promotes and protects the health of the public throughout drug development, during the drug review process, and in continued safety monitoring following drug approval. To accomplish its mission, CDER must contend with many important challenges.

A number of these challenges relate to activities included in the process for the review of new innovator drugs, now supported by prescription drug user fees. More than two decades ago, Congress responded to concerns about delays in the availability of new drugs in the US compared to Europe, by passing the Prescription Drug User Fee Act of 1992, providing additional funding and setting performance goals for FDA new drug review. Since then, FDA has become a world leader in rapid drug review and earlier patient access to new medicines, with over 1,000 new drugs approved for the US market. The increase in effective treatments for disease has extended the average lifespan for Americans. It also means that more Americans are living with multiple chronic disease conditions and relying on chronic use of multiple drug therapies. Thus more patients have a greater cumulative exposure to the risk of adverse effects from drug therapy.

In addition, healthcare is now delivered in settings ranging from inpatient specialty care hospitals to nursing homes and informal family care arrangements, and provided by care-givers with greatly varying levels of technical skill and access to drug safety information and health information technologies. Fifteen years ago most patients would have obtained information about their disease condition and medicines from their family physician – who served as a “learned intermediary” in health care decisions – today, patients typically obtain their information from the Internet, direct-to-consumer advertising and other sources of varying quality and accuracy. And rather than play a passive role in health decisions, patients increasingly expect to be treated as a partner in managing their care. In this context, CDER must ensure that accurate and up-to-date information is available to both patients and health care providers to ensure the appropriate and safe use of medicines once they are approved and marketed.

As more innovator drugs reach patent expiry generic drugs account for a growing share of prescription medicine sales in the US, increasing to 80% in 2013 from 66% in 2008. While this increase has resulted in substantial savings to US healthcare consumers, it has also resulted in new challenges for CDER, given a historically limited capacity to conduct generic drug review, resulting in a substantial backlog of pending generic drug applications. In 2012, Congress passed the Generic Drug User Fee Amendments (GDUFA) to speed access to safe and effective generic drugs to the public and to enhance the efficiency and effectiveness of the generic drug review process. The additional resources obtained through industry user fees under GDUFA will enable CDER to reduce the backlog of pending generic drug applications, decrease review times, and conduct more timely domestic and foreign facility inspections. With GDUFA in place, CDER’s challenge is to meet its user fee performance commitments for timely drug application review and develop effective risk-based inspection methods.

CDER is addressing other challenges related to drug quality. The manufacture and distribution of drugs has changed in ways that impact CDER and the public health, becoming more dispersed and complex. Pharmaceutical manufacturing operations have been rapidly shifting from operations concentrated in the US and other developed countries to production facilities in distant and less developed countries, particularly India and China. In addition, pharmaceutical companies with drugs approved for marketing often use contract manufacturers to produce their drugs. The increasing complexity of the supply chain led to new authorities for FDA under the FDA Science and Innovation Act of 2012, to better monitor the safety and integrity of the US drug supply chain.

And more recently, on the domestic front, a number of drugs are being manufactured or repackaged at large-scale compounding facilities rather than more traditional pharmaceutical production facilities. FDA regulatory authority and oversight of these facilities was only recently clarified, yet the importance of ensuring that drugs produced at compounding facilities are safe and effective increases as the share of drugs produced at such facilities increases.

In general, CDER must accomplish its mission and address the increasing complexity of its operating environment by applying information and analytic strategies that will enable success even in the face of limited resources. CDER is interested in exploring, applying and evaluating more formalized and comprehensive approaches to analysis and impact assessment that could inform and enhance CDER strategies, actions and decisions.

2.2 OBJECTIVE

Engage expert consultants to provide technical assistance in identifying, developing, enhancing, applying or evaluating a wide range of quantitative and qualitative methods drawn from decision science, risk analysis, social science, health outcomes research, health systems research, health economics and other analytic disciplines. These methods will be applied in a variety of projects to enable FDA to use more comprehensive and rigorous methods of analysis, measures of effectiveness, measures of quality, and measures of value and other impacts on consumers, on public health, healthcare, regulated industry and other stakeholders.

2.3 SCOPE OF WORK

The contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below and in individual task orders. The contractor shall be prepared to develop a response to individual tasks as they are issued. This will be a multiple vendor award contract with multiple task orders during the contract’s anticipated five year period. Awardees will compete for individual task orders as they are released by FDA.

The contractor shall specify the methods it will employ in accomplishing the key tasks of each task order. The key task may include:

1. Provide technical assistance in identifying, developing, enhancing, applying and evaluating more formalized approaches to center analysis and impact assessment.

2. Develop a study design and plan, applying decision science, social science, risk analysis, economic, mathematical and statistical, or other methods of analysis as appropriate for each task.

3. Develop plans to identify and obtain data necessary to complete the specified analytic task and related evaluation.

4. Conduct surveys and analysis of literature relevant to the identified dimensions of risk, benefit, quality, effectiveness or other impact analysis for the specified task.

5. Conduct reviews and analysis of FDA-provided relevant primary data, including non-clinical data and clinical data collected in clinical studies, if required for the specific task.

6. Identify and analyze potential advantages and disadvantages of existing and available methods to systematically evaluate risk, benefit, quality, effectiveness, uncertainty or other dimensions of impact relevant to the specified task.

7. Conduct sophisticated modeling and analysis methods drawing from the literature and current best practice in decision analysis, risk analysis, economics, including pharmacoeconomics, and medical outcomes research.

8. Develop new methods and models applying appropriate mathematical and statistical techniques to account for the features of specific health impact questions, issues and related needs for analysis and decision support

9. Analyze program parameters as appropriate using FDA data systems, to assess the applicability and performance of more formalized methods in the actual operational context of center decision making processes.

10. Provide briefing to the agency on draft deliverables and findings, e.g., following literature reviews, proposed approaches to analysis, the findings of conducted analyses, and other tasks, to obtain agency input.

Tasks

Examples of tasks of interest that might be ordered under this contract may include, but are not limited to:

1. Provide technical assistance in identifying, applying and evaluating more formalized approaches to benefit-risk analysis of non-prescription drugs.

2. Provide technical assistance in identifying, applying and evaluating more formalized approaches for applying benefit-risk analysis to drugs after they have received FDA marketing approval.

3. Provide technical assistance in collecting, linking, and/or migrating pre-approval and post-approval drug information across internal or external data systems.

4. Develop data, methods, metrics and analysis on the use of Patient Reported Outcomes (PROs) in drug research, development and regulatory review.

5. Conduct qualitative and quantitative analysis of health impact and costs of specified FDA policies, including but not limited to, Risk Evaluation and Mitigation Strategies (REMS).

6. Develop and test standards for tracking drugs as they travel through the drug supply chain.

7. Develop methodologies for analysis and analysis of hospital pharmaceutical selection methods with focus on purchasing compounded pharmaceuticals from an outside pharmacy.

8. Develop and evaluate new ways to measure the benefit and other impacts of maintaining acceptable good manufacturing industry practice by proactively identifying problematic FDA inspection findings in ongoing surveillance programs to identify and prevent emerging problems that would otherwise lead to substandard product quality.

9. Review existing processes by which healthcare providers receive “Continuing Medical Education” (CME). Evaluate the feasibility of incorporating drug risk management programs (e.g. REMS) into CME systems or of replacing current CME with sources through which physicians, patients and others currently learn about drug risks.

10. Examine and review systems currently used by sponsors to manage Risk Evaluation and Mitigation Strategies (REMS). Identify methods for sharing risk information across systems.

2.4 LABOR CATEGORIES DESCRIPTIONS

Analyst - Under direct supervision, shall assist with the review and analysis of customer requirements or problems and the development of proposals of cost effective solutions. Shall assist Analysts and Consultants in developing detailed documentation and specifications. Under close supervision, performs basic quantitative or qualitative analyses to assist in the identification of customer issues and the development of customer specific solutions. Shall assist other Analysts and/or Consultants in design and structures of presentations that are appropriate to the characteristics or needs of the audience. Continualy develops a basic knowledge of consulting methodologies and the marketplace through the delivery of consulting engagements and participation in formal and informal learning opportunities. Engagement based responsibilities are assigned and closely managed by consultants, engagement managers or principals. Preferred experience - 1-3 years. Education - BS or equivalent Consultant - Similar responsibilities and duties as an Analyst but performed more independently and at a higher level of ability. Proactively develops a basic knowledge of consulting methodologies and the market place throught consulting engagements and participation in formal and informal learning opportunities. Engagement basede responsibilities are assigned and closely managed by engagement managers or principals. Experience – 3-5 years. Education – BS or equivalent.

Senior Consultant - Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects. Reviews and analyzes customer requirements or problems and assists in the development of cost effective solutions that ensure high customer satisfaction. Provides direction and guidance to Analysts and Consultants assigned to engagement. Develops detailed documentation and specifications. Performs qualitative and/or quantitative analyses to assist in the identification of customer issues and the development of customer specific solutions. Designs, structures and delivers customer reports and presentations that are appropriate to the characteristics or needs of the audience. Recommends improvements and alternative solutions to resolve problems. Provides follow-up with customer after project deliverable has been completed to ensure customer satisfaction. Proactively develops broader and deeper knowledge of related consulting methodologies through on the job experience and participation in training opportunities. Begins to develop practice specific subject matter expertise. Experience – 5-8 years. Education – BS or equivalent Principal 2 - Primary owner of customer engagements with ultimate responsibility for customer satisfaction and delivering high levels of quality/added value. Meets or exceeds customer expectations by developing and delivering insightful, value-added solutions that address complex customer issues. Responsible for significant and tangible customer impact from all engagements. Customer manages customer interface and project team to achieve efficient and effective project delivery. Serves as a solutions-based expert, internally and externally, by applying consultative problem solving skills. Identifies issues of importance to the industry/customers and works with the Practice Leader to develop tangible effective solutions. Maintains in-depth and extremely current knowledge of customer’s strategies, business issues and relationships from senior management on down. Remains current on industry, customer and market trends and directions in order to anticipate and identify new business challenges and issues.customer. Contributes to the expert body of knowledge in the market place, e.g. through speaking engagements, customer meetings, publications etc. Proactively continues to strengthen subject matter expertise through on the job experience, participation in conferences and symposiums and other forums for professional knowledge sharing. Proactively mentors, coaches and shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for customers. May have responsibility for managing one or more Principals. Experience – 10 years. Education – BS or greater Principal 1 - Similar responsibilities and duties as a Principal 2 performed at a higher level of ability and possessing greater experience and subject matter expertise. May have responsibility for manag other principals. Experience – 10 years. Education – BS or greater.

SECTION 3 - PACKAGING AND MARKING

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

SECTION 4 - 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 Food and Drug Administration 10903 New Hampshire Ave Building 51 Silver Spring, Maryland 20993

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

SECTION 5 - DELIVERIES OR PERFORMANCE

Deliverables shall be established with the issuance of each task order.

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 reports electronically in Microsoft Word 2007 compatible format with 12 point font to the COR. The Contractor shall submit all data to the COR in SAS transport (.xpt) and/or Microsoft Excel (.xlsx) format. The Contractor shall confirm all electronic documents submitted to the FDA are virus free before transmittal to the FDA.

5.1 ANTICIPATED TASKS AND DELIVERABLES

NOTE: The FDA will delineate actual tasks and deliverables and their schedules with the issuance of each task order. The following are illustrative examples of future anticipated tasks and deliverables for a task order:

Kickoff Meeting: Within 10 business days of the effective date of a task order, the Contractor shall conduct a kickoff meeting with the COR and other appropriate FDA staff and within two business days after the kickoff meeting provide the COR with meeting notes, including a summary of discussions, action items, and due dates.

Study Protocol: Within 45 business days of the kickoff meeting, the Contractor shall provide complete study protocol documents to the COR and provide revised study protocol materials within 10 business days of the FDA providing feedback on the draft materials.

Biweekly Teleconferences: For all Task Orders, the Contractor shall conduct teleconferences with the COR and other appropriate FDA staff every two weeks and within two business days after each teleconference provide the COR with meeting notes, including a summary of discussions, action items, and due dates.

Monthly Progress Reports: For All Task Orders The Contractor shall provide the COR with a monthly progress report by the 10th day of each month for the prior month’s reporting period, which shall include a clear account of the work performed during the reporting period; an outline of the work to be accomplished during the next reporting period; for labor hour order, hours expended during the reporting period and an account of total hours worked throughout the period of performance of the order; and 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 or anticipated.

Scientific Reports: The Contractor shall provide the COR a scientific report on the order’s data, findings, analysis, and results 30 business days before the end of the period of performance of the task order.

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).

5.2 Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) The Government may provide Government Furnished Property for use in direct performance of each task order. Each task order will specify if Government Furnished Property will be provided.

In addition to the requirements of the clause, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at: http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf

5.3 Security

It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer.

5.4 Travel

Travel will be required for meetings with FDA Project officer and Technical Advisory Group, as required by the Task Order Statement of Work and designated by the Project Officer.

5.5 ORDERING PERIOD

The FDA may issue task orders up to the final day of the contract, and the contract shall remain in force to allow for the completion of all task orders. The FDA will not issue, and the Contractor shall not accept, any new task orders issued after expiration of the contract’s period of performance.

5.6 Period of Performance

The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.

5.7 Option Periods

The Government may elect to include four option periods as described below (exact dates will be adjusted at award):

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 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 DATA

6.1 Ordering Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the services being ordered and shall be competed among all the awardees. All task orders issued under this contract shall conform to the provisions of the contract clause in Section I entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

Task Ordering 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 orders 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. The SOW will include, at a minimum, the following elements:

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

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

3. Period and place of performance

4. Reporting requirements and Deliverables

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

b) Requests for Task Order Proposals (RTOPs) shall only be issued by the 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 RTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

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

6.2 Contracting Officers Representative (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award) The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

James Chestnut James.Chestnut@fda.hhs.gov Tel: (240) 402-7570; Fax: (240) 402-7570

The contact information for the Contract Specialist is:

The contact information for the Ombudsman is:

Glenda Barfell Glenda.Barfell@fda.hhs.gov Tel: (240) 402-7562; Fax: (301) 827-7151

6.3 Invoice Submission

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

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Lacetta T. Bowman, Contracting Specialist 5630 Fishers Lane Room 2050A, HFA-500 Rockville, MD 20852 Email: Lacetta.Bowman@fda.hhs.gov

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

(II) One copy to the contracting officer ‘s representative (COR), clearly marked “Courtesy Copy Only”:

U.S. Food and Drug Administration ATTN: (To be determined upon contract award); COR Address:

Email: XXXXX@fda.hhs.gov

*****Acceptable methods of delivery include: mail, hand delivery and email***** B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – 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;

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

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

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

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

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

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

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.

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

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:

OFS Contracts Invoice Payment 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 OFS/PaymentServices@fda.hhs.gov

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

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

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

7.1 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

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

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

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

7.2 Accountability and Security

All Contractor and subcontractor employees who will have access to Government information and/or sensitive materials must sign a Confidentiality Agreement. It is the responsibility of the Contractor to assure that such Agreements have been signed before access is permitted. Copies of signed agreements should be provided to the Task Order COR.

7.3 508 Standard Requirements *This will be identified in the Task Orders

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

7.5 Security and Privacy

Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. Personnel assigned to this contract shall be required to complete and undergo a National Agency Check Inquiry (NACI) before the contractor employee may be issued an identification badge as well as bill to the contract (not prior to assignment). Unfavorable information security check results will be reported to GSA and appropriate action taken.

Because of the sensitivity of much of the FDA data, contractor staff shall also be required to undergo a Level 5 Public Trust security clearance, including finger printing, performed under the auspices of the FDA.

The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government.

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

Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the task order that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the task order. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

HHS policy requires contractors/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 each contractor/subcontractor employee has completed the FDA Computer Security Awareness Training course prior to performing any contract work and thereafter annually during the period of performance of the contract. HHS may change, add or modify Computer Security Awareness training requirements to enhance the HHS computer security program.

Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete and submit the FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer or designee prior to performing any work under the contract. The Project officer or designee will inform the contractor of any additional forms and training that are required. (See Attached)

7.6 Travel and Per Diem

Travel and Per Diem authorized under this contract shall be reimbursed in accordance with the Federal Travel Regulations currently in effect. Per Diem rates shall not exceed the Government approved rates in effect (http://www.gsa.gov/portal/category/21287).

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

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)

Alternate I (MAY 2014). When a time-and-materials or labor-hour contract is contemplated, substitute the following paragraphs (a), (e), (i), (l), and (m) for those in the basic clause.

52.216-27, SINGLE OR MULTIPLE AWARDS (OCT 1995)

52.227-14, RIGHTS IN DATA - GENERAL (MAY 2014), ALTERNATE V (DEC 2007)

Alternate V (Dec 2007). As prescribed in 27.409(b)(6), add the following paragraph (j) to the basic clause:

(j) The Contractor agrees, except as may be otherwise specified in this contract for specific data deliverables listed as not subject to this paragraph, that the Contracting Officer may, up to three years after acceptance of all deliverables under this contract, inspect at the Contractor’s facility any data withheld pursuant to paragraph (g)(1) of this clause, for purposes of verifying the Contractor’s assertion of limited rights or restricted rights status of the data or for evaluating work performance. When the Contractor whose data are to be inspected demonstrates to the Contracting Officer that there would be a possible conflict of interest if a particular representative made the inspection, the Contracting Officer shall designate an alternate inspector.

52.227-16, ADDITIONAL DATA REQUIREMENTS (JUN 1987)

52.232-23, ASSIGNMENT OF CLAIMS (MAY 2014)

52.232-40, PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

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

52.249-14, EXCUSABLE DELAYS (APR 1984)

8.2 FAR CLAUSES BY FULL TEXT

FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS (MARCH 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) 52.222-50, 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) (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).

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

__X_ (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).

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

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

___ (12) 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).

___ (13) [Reserved] __ (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 (May 2014) (15 U.S.C. 637(d)(2) and (3)).

__X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)).

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

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

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

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

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

__X_ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

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

___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (27) 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_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X__ (29) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126).

_X__ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

X_ (32) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

X_ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

X_ (34) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

X_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X_ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (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.)

___ (37) (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.)

____(38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) + (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

_ (43) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (44) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III…