10-223-SOL-00082 board copy.doc

Table of Contents

10-223-SOL-00082

Section 1

Addendum – Continuation of SF-1449 (Prices/Performance/Costs)

Section 2

Contract Clauses/Contract Clause Addendum

Section 3

Contract Documents

Appendices

Appendix A: General Outline for Applicable SOP’s in Support of Legacy Systems

Appendix B: Data Management Adverse Event Receipt Estimates by Center

Appendix C: Section 508 of the Rehabilitation Act of 1973

Appendix D: Labor Category Descriptions

Appendix E: CDER Secure Electronic Mail System

Appendix F: Legislation Requirements

Appendix G: Standardize Key Data Elements

Appendix H: Glossary/Terms

Appendix I: Wage Determination

Appendix J: Past Performance Questionnaire

Section 4 Solicitation Provisions/Solicitation Provision Addendum

Section 5

Evaluation Criteria

Section 6 Offeror Representations and Certifications

Attachment 1 Task Order 1 Section 1

Addendum – Continuation of SF-1449 Prices/Performance/Costs

1.1 BACKGROUNDtc "BACKGROUND" \f C \l 1

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of all FDA regulated products such as human and veterinary drugs, biological products, medical devices, food and dietary supplements, cosmetics, and products that emit radiation. For each respective Center within FDA, legislation is set forth for voluntary and mandatory reporting of adverse events, product problems or complaints, and Good Manufacturing Practices (GMPs) as cited in the Federal Food, Drug and Cosmetic Act and the Public Health Service Act and other laws affecting the FDA. FDA receives these reports by electronic submission, mail, phone, fax, email, and via the internet. FDA requires support services for data entry and processing received reports. The key source of data entry includes Individual Case Safety Reports (ICSRs).1 These ICSRs are submitted to each Center in various formats. Currently, each Center has individual programs in place for supporting these legislative mandates and their respective missions. This contract shall provide the opportunity and means to align the individual Center programs with the Agency goal of a Unified Adverse Event Data Management Program, hereafter referred to as the Data Management Program (DMP).

The FDA Center’s missions and legislative authorization are presented below for FDA regulated products:

The FDA Center for Drug Evaluation and Research (CDER) and the FDA Center for Biologic Evaluation and Research (CBER) perform a crucial part of FDA's mission, pre-market and post-market safety and efficacy assessments of human drugs and biological products. The collection and analysis of reports by FDA staff must occur throughout the entire life cycle of the product in order to identify occurrences associated with the use of a drug or biologic in humans that could not have been predicted by such methods as clinical trials and bio-statistical analysis. These occurrences of adverse events or product problems must be reported to FDA in order for the Agency to carry out its mission protecting the U.S. public health. CDER and CBER receive reports submitted by stakeholders such as manufacturers, importers, health care professionals, and consumers. In addition, FDA employees may obtain follow-up information and submit reports from the FDA field offices.

For CDER and CBER the statutory provisions for FDA’s requirement to record mandatory submission of adverse drug reports for an Investigational New Drug Application (IND) or New Drug Application (NDA), Abbreviated New Drug Application (ANDA,) Biologic Licensing Application (BLA)and OTC products in an adverse event reporting system is Section 505(k))(1)2 of the Federal Food, Drug and Cosmetic Act, 21 CFR 310.305, 312.32, 314.80 and 600.80, Public Health Service Act, and Public law 109-462

Medical Dictionary for Regulatory Activities (MedDRA), is a standardized international terminology for coding of medical information for regulatory communication. MedDRA was developed by the International Conference on Harmonisation (ICH); it is used in electronic transmission of Individual Case Safety Reports (ICSRs) following the ICH E2B standards. MedDRA enables medical accuracy and transparency in coding, and standardized communication of coded data between manufacturers/sponsors and regulators.

The FDA Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices. CDRH has the responsibility for post-market surveillance such as monitoring the performance, safety, and effectiveness of marketed medical devices. The objective of post-market surveillance is to protect the public from actual or potential hazards associated with medical devices. CDRH receives device event reports submitted by stakeholders such as medical device manufacturers, importers, user facilities, health care professionals and consumers.

Section 519 of the Federal Food Drug and Cosmetic Act authorized CDRH to record mandatory submission of reports to protect the public from actual or potential hazards associated with medical devices. The MDR Regulation (21 CFR Part 803) establishes the requirements for the mandatory reporting of adverse events involving medical devices. The Medical Device Amendments to the FD&C were enacted on May 28, 1976. The FD&C Act was amended again in 1997 by the Food and Drug Administration Modernization Act (FDAMA), which provide for streamlining the process of bringing safe and effective medical devices to the U.S. Market.

Enactment of the Safe Medical Device Act of 1990 (SMDA) and the 1992 Medical Device Amendment made a significant impact upon the mandatory aspects of CDRH’s post-market surveillance program. In accordance with the MDR regulation 21 CFR Part 803.32 and 803.40, these revisions created an obligation for user facilities to report deaths and importers to report deaths and serious injuries directly to FDA and to the manufacturer.

The mission of the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) is to protect the public health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and properly labeled, and that cosmetic products are safe and properly labeled. CFSAN-regulated products include dairy products, plant foods, beverages, seafood, dietary supplements, cosmetic products, infant formula, medical foods, and color additives to food. The CFSAN Adverse Event Reporting System (CAERS) is a post‑marketing surveillance system to collect, analyze, monitor, and report adverse events and product complaints for CFSAN regulated products. Both mandatory and voluntary reporting of adverse events and product complaints are processed through CAERS. In addition, specific legislation may require Centers to maintain stand-alone tracking systems such as infant formula and bioterrorism. Mandatory reporting for dietary supplements is authorized under the Federal Food, Drug and Cosmetic (FFD&C) Act Section 761 and mandatory reporting for reportable food is authorized under FFD&C Section 417.

The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula (Section 417 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f)). Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report to FDA when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Federal, state, and local Government officials may also use the RFR portal to report information that may come to them about reportable foods.

The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species.

Post-marketing surveillance affords the primary means by which CVM obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product and manufacturing problems. CVM receives reports submitted by stakeholders such as: manufacturers, importers, health care professionals, and consumers. This contract, at the present time, will only address post-marketing safety reporting. The scope may broaden to include premarketing in the future.

Section 512(l) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(l), and § 514.80(b) of FDA regulations (21 CFR 514.80) requires applicants of approved animal drugs to report adverse drug experiences and product and manufacturing defects. Product and manufacturing defects must be reported if they meet the criteria in 21 CFR 514.80(b)(1). Adverse drug events and product and manufacturing defects involving animals must be submitted based on the criteria in 21 CFR 514.80 (b)(2)(i) and (ii), and (4)(iv). Voluntary reports are also accepted from consumers and veterinarians.

The Tobacco Control Act enacted by Congress and signed by the President in June 2009 created the Center for Tobacco Products (CTP). As the mission of this Center is developed, reporting regulations will be defined and may require collection of adverse event reports related to products that the Center regulates. This Center will be eligible to have a task order under this Agency-wide contract.

Over time, FDA intends to replace multiple current legacy processes and data systems that are used for the receipt, processing, validation, and assessment of received reports. These transitions may require the adoption of new software, revised SOPs, and additional staff training under this contract. Additionally, FDA intends to adopt emerging data exchange standards which may impact future electronic submission procedures. FDA is in the early stages of transitioning to a single electronic internet portal for adverse event and product problem reporting for all products. This portal will be known as the Safety Reporting Portal. The Safety Reporting Portal will allow reports to be typed into a "rational questionnaire" internet application that tailors questions based on the type of report, product, event, etc. As FDA transitions to new technologies, it is expected that tasks under this contract will be impacted. These impacts will need to be assessed as they occur and modifications to task orders under this contract may need to be considered.

1.2 OBJECTIVEStc "OBJECTIVES" \f C \l 1

The objectives of the Data Management Program (DMP) are to obtain the services of a single Contractor to provide qualified support for:

1. Processing reports commonly known as Individual Case Safety Reports (ICSRs) such as triaging, registering (logging), tracking, imaging or scanning, data entry, data entry quality control, updating of data records (to include resolving duplicates and conflicting information), reviewing, editing, coding, coding quality control (QC), coding quality assurance (QA), filing and redacting, distributing, archiving, and shredding of physical media. Specific controlled vocabularies are utilized by each Center to standardize key data elements.

2. Processing incoming supplemental ICSR information from follow-up requests as outlined in item number one to include updating and linking to the existing database records.

3. Managing the receipt of ICSRs through various means such as fax, phone, mail, e-mail, compact disk, electronic gateway records, and other electronic systems such as Office of Regulatory Affairs’ Field Accomplishments and Compliance Tracking System (FACTS) and Emergency Operations Network (EON) which will require extraction, verification and coding of incoming data.

4. Route ICSRs sent to the FDA to the appropriate Center or Federal Agency.

5. Re-route ICSRs sent to the FDA in error to the appropriate Center or Federal Agency.

6. Processing incomplete ICSRs as required by each Center.

7. Sending FDA generated letters as required by each Center.

8. Tracking, routing and processing paper periodic summary reports (PSUR or PADR) as required by each Center.

9. Processing requests for information such as FOIA requests as required by each Center.

10. Providing statistical reports of work accomplished including performance reports and ICSR statistics in various formats as required by each Center.

11. Organizing, planning, and attending progress meetings between the Contractor’s Project Manager and the FDA COTR (or his/her designees).

12. Maintaining operational logs, manuals, and checklists as required by each Center.

13. Developing and/or maintaining Standard Operating Procedures and monitoring Business Rules as required by each Center.

14. Providing a Management Plan to include the implementation of Communication, Quality Control, Training, and Contingency plans.

15. Performing User Acceptance Testing (UAT) of DMP system upgrades and providing feedback prior to the release of software into the production environment.

16. Providing a technical lead that will liaison with designated FDA IT support staff regarding performance issues.

17. Responding to changes in the processing of ICSRs as the Agency transitions to a new web-based data entry system, Safety Reporting Portal, and the Rational Questionnaire and implementation of the Food and Drug Adverse Event Reporting System (FAERS) or other upgraded or new software systems.

18. An initial start-up time period shall be required to establish all standard operating procedures, train personnel for data entry services, and have any required tracking systems developed in order to be fully operational as determined by each Center.

1.3 CONTRACT VEHICLE / TASK ORDERS

As requirements are identified by the FDA, the Contracting Officer (CO) shall issue Individual Task Orders (ITOs) against the Master Contract. The ITOs shall be issued with a specific Statement of Work (SOW), funding document, and will have a designated Contracting Officers Technical Representative (COTR).

The Master Contract period of performance shall have a five (5) year ordering period. Use of this contract vehicle implies that all participating individual task order COTR’s will work cooperatively with the designated Master Contract COTR, the Office of Acquisitions and Grants Services, follow all applicable laws and regulations, and only request services that are within the scope of this contract. The ITO COTR shall be responsible for obtaining consent for use of this contract vehicle from the designated Master Contract COTR. The CO shall be responsible for negotiating all ITOs, issuing all ITOs, receiving reports, approving invoices, overseeing all financial transactions, and implementing all Master Contract and ITO modifications, as needed.

It is anticipated that the ITOs issued against this contract vehicle will be Firm-Fixed-Price (FFP). However, other types of individual task orders may also be placed under this contract, such as a Time and Materials /Labor Hour (T&M) Task Orders. All deliverables shall be clearly identified, complete with clear descriptions; due dates, and at a predetermined, agreed-upon price. If practicable, the ITOs shall be performance based with specific, measurable performance standards that shall be clearly identified, logical, and practicable.

A period of performance will be specified for each ITO. The SOW for each ITO shall specify any special acceptability standards for each deliverable, and all payments shall be made subject to the ITO COTR’s acceptance. The ITO COTR shall have full project oversight responsibility for the work completed under the respective ITO. However, all ITO requirements and subsequent modifications shall be provided to the Master Contract COTR to ensure compatibility with the existing scope of work.

The CO shall be the only Government Representative authorized to make any changes which either decrease or increase the Master Contract or ITO SOW or price. In addition, the CO is the only Government Representative authorized to change any terms or conditions of the Master Contract or any respective ITO. Any proposed revisions shall be referred to the CO and shall require the submittal of a modification request, as well as concurrence from the designated COTR.

The ITO COTR’s shall submit a written report to the designated Master Contract COTR and CO at the completion of each ITO. The report shall include the following information: any changes made to the original SOW, any respective changes to ITO price with a complete breakdown of price allocation, and a complete contractor performance evaluation.

All ITO’s created using this Master Contract will use pricing derived from the following pricing schedule.

1.4 Pricing Schedule IDIQ

Year 1: July 1, 2010 – June 30, 2011

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Veterinary Technicians

Veterinarian

Year 2: July 1, 2011 – June 30, 2012

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Veterinary Technicians

Veterinarian

Year 3: July 1, 2012 – June 30, 2013

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Veterinary Technicians

Veterinarian

Year 4: July 1, 2013 – June 30, 2014

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Veterinary Technicians

Veterinarian

Year 5: July 1, 2014 – June 30, 2015

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Veterinary Technicians

Veterinarian

NOTE: Additional labor categories can be added as necessary and the rates will be negotiated at the time of inclusion. See Appendix D for detailed Labor Category Descriptions.

1.5 INDEFINITE QUANTITY INDEFINITE DELIVERY (IDIQ) PORTION

a. Payment will be made in accordance with the pricing schedule set forth in each ITO and receipt of a proper voucher/invoice.

b. Fully Loaded Labor Rates (see Pricing Schedule IDIQ) provided shall be applicable for the duration of this contract.

c. As consideration for performance of the work stated in the individual task order SOW, the Government will pay the Contractor based on the type of contract awarded.

1.6 MINIMUM AND MAXIMUM QUANTITIES

As referred to in paragraph (b) of the “Indefinite Quantities” clause of this contract, the contract guaranteed minimum is satisfied with the award of the first task order. The maximum of all orders issued and awarded under this contract will not exceed $90,000,000.00.

1.7 TRAVEL EXPENSES

Travel costs, if any, will be negotiated and identified in the Individual Task Orders as a separate line items and shall be reimbursed in accordance with FAR 31.205-46.

Section 2 Contract Clauses/Contract Clause Addendum

2.1 52.212-4 Contract Terms and Conditions - Commercial Items. (MAR 2009)

2.2 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items. (FEB 2010)

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

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

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

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

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

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

[ X ](1) 52.203-6, Restrictions on Subcontractor Sales to the Government (SEP 2006), with Alternate I (OCT 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

[ X ](2) 52.203-13, Contractor Code of Business Ethics and Conduct (DEC 2008)(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 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[ ](4) 52.204-11, American Recovery and Reinvestment Act--Reporting Requirements (MAR 2009) (Pub. L. 111-5).

[ ](5) 52.219-3, Notice of Total HUBZone Set-Aside (JAN 1999) (15 U.S.C. 657a).

[ ](6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JUL 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[ ](7) Reserved.

[ X ](8)(i) 52.219-6, Notice of Total Small Business Set-Aside (JUN 2003) (15 U.S.C. 644).

[ ](ii) Alternate I (OCT 1995) of 52.219-6.

[ ] (iii) Alternate II (MAR 2004) of 52.219-6.

[ ](9)(i) 52.219-7, Notice of Partial Small Business Set-Aside (JUN 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 ](10) 52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C. 637 (d)(2) and (3)).

[ ](11)(i) 52.219-9, Small Business Subcontracting Plan (APR 2008) (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.

[ X ](12) 52.219-14, Limitations on Subcontracting (DEC 1996) (15 U.S.C. 637(a)(14)).

[ ](13) 52.219-16, Liquidated Damages--Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[ ](14)(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 (JUN 2003) of 52.219-23.

[ ](15) 52.219-25, Small Disadvantaged Business Participation Program--Disadvantaged Status and Reporting (APR 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

[ ](16) 52.219-26, Small Disadvantaged Business Participation Program--Incentive Subcontracting (OCT 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

[ ](17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004)(15 U.S.C. 657 f).

[ X ](18) 52.219-28, Post Award Small Business Program Rerepresentation (APR 2009) (15 U.S.C. 632(a)(2)).

[ X ](19) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[ ](20) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (AUG 2009) (E.O. 13126).

[ X ](21) 52.222-21, Prohibition of Segregated Facilities (FEB 1999).

[ X ](22) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246).

[ X ](23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212).

[ X ](24) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793).

[ X ](25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212).

[ X ](26) 52.222-54, Employment Eligibility Verification (Jan 2009). (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.)

[ ](27)(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.)

[ ](28) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

[ ](29)(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.

[ ](30) 52.225-1, Buy American Act - Supplies (FEB 2009) (41 U.S.C. 10a-10d).

[ ](31)(i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (JUN 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138).

[ ](ii) Alternate I (JAN 2004) of 52.225-3.

[ ](iii) Alternate II (JAN 2004) of 52.225-3.

[ ](32) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[ X ](33) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[ ](34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[ ](35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[ ](36) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

[ ](37) 52.232-30, Installment Payments for Commercial Items (OCT 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

[ X ](38) 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003) (31 U.S.C. 3332).

[ ](39) 52.232-34, Payment by Electronic Funds Transfer - Other than Central Contractor Registration (MAY 1999) (31 U.S.C. 3332).

[ ](40) 52.232-36, Payment by Third Party (MAY 1999) (31 U.S.C. 3332).

[ ](41) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[ ](42)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

[ ](ii) Alternate I (APR 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)

[ X ](1) 52.222-41, Service Contract Act of 1965 (NOV 2007) (41 U.S.C. 351, et seq.).

[ X ](2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

[ X ](3) 52.222-43, Fair Labor Standards Act and Service Contract Act--Price Adjustment (Multiple Year and Option Contracts) (SEP 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

[ ](4) 52.222-44, Fair Labor Standards Act and Service Contract Act--Price Adjustment (SEP 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

[ ](5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (NOV 2007) (41 U.S.C. 351, et seq.).

[ ](6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (FEB 2009) (41 U.S.C. 351, et seq.).

[ ](7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (MAR 2009) (Pub. L. 110-247).

[ ](8) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records - Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause--

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (DEC 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) Reserved.

(iv) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793).

(vii) Reserved.

(viii) 52.222-41, Service Contract Act of 1965 (NOV 2007) (41 U.S.C. 351, et seq.).

(ix) 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)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (NOV 2007) (41 U.S.C. 351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (FEB 2009)(41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (Jan 2009).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (MAR 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

2.3 Contract Clauses Incorporated by Reference

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE, as provided herein. See FAR 52.252-2 for an Internet address (if specified) for electronic access to the full text of a clause.

NUMBER

TITLE

DATE

52.203-6

Alternate I Restrictions on Subcontractor Sales to

SEP 2006

the Government

52.212-4

Alternate I Time-and-Materials or Labor-Hour Contract

OCT 2008

52.228-5

Insurance – Work on a Government Installation

JAN 1997

52.232-7

Payment Under Time-and-Material and Labor-

FEB 2007

Hour Contracts

52-237-2

Protection of Government Buildings, Equipment, APR 1984

And Vegetation 52.242-15

Stop-Work Order

AUG 1989

52.244-2

Subcontracts

JUN 2007

52.245-1

Government Property

52.245-9

Use and Charges

52.248-1

Value Engineering

FEB 2000

52.253-1

Computer Generated Forms

JAN 1991

https://www.acquisition.gov/far/

2.4 52.216-18 Ordering (OCT 1995)

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

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

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

2.4.1 Instructions for Placing and Negotiating Individual Task Orders

When the Government anticipates issuing an ITO for services, the Government will provide the contractor with an ITO SOW and request that the contractor submit a written work plan. Within 14 calendar days after receipt of a request and a task description from the Government, the contractor shall submit one (1) copy of a written work plan to the CO. Alternatively; the Government may require an oral proposal/work plan covering any or all of the written work plan requirements listed below. The format and content of the work plan shall be substantially the same as the work plan that the contractor submitted with its original proposal. The work plan shall include:

· A work schedule including the estimated date of commencement of work after issuance of the task order by the CO

· A detailed price proposal, utilizing the rates in the contractor’s proposed cost/pricing schedule for the Master Contract, in addition to the total estimated price

· Specific plans for dealing with anticipated problems that may be encountered

Offers shall remain valid for at least 60 days from date of submission

2.5 52.216-19 Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

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

(1) Any order for a single item in excess of $1,000,000.;

(2) Any order for a combination of items in excess of $10,000,000; or

(3) A series of orders from the same ordering office within 60 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

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

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 15 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

2.6 52.216-22 Indefinite Quantity (OCT 1995)

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

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

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

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

2.7 52.217-8 Option to Extend Services (NOV 1999)

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

2.8 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor anytime prior to the expiration date of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend anytime prior to the expiration date of the contract. The preliminary notice does not commit the Government to an extension.

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

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

2.9 52.219-11 Special 8(a) Contract Conditions (Feb 1990) The Small Business Administration (SBA) agrees to the following:

(a) To furnish the supplies or services set forth in this contract according to the specifications and the terms and conditions hereof by subcontracting with an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(b) That in the event SBA does not award a subcontract for all or a part of the work hereunder, this contract may be terminated either in whole or in part without cost to either party.

(c) Except for novation agreements and advance payments, delegate to the Food and Drug Administration the responsibility for administering the subcontract to be awarded hereunder with complete authority to take any action on behalf of the Government under the terms and conditions of the subcontract; provided, however, that the Food and Drug Administration shall give advance notice to the SBA before it issues a final notice terminating the right of a subcontractor to proceed with further performance, either in whole or in part, under the subcontract for default or for the convenience of the Government.

(d) That payments to be made under any subcontract awarded under this contract will be made directly to the subcontractor by the Food and Drug Administration.

(e) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the Contracting Officer cognizable under the “Disputes” clause of said subcontract.

(f) To notify the Food and Drug Administration Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

2.10 52.219-12 Special 8(a) Subcontract Conditions (Feb 1990)

(a) The Small Business Administration (SBA) has entered into Contract No.________ [insert number of contract] with the Food and Drug Administration to furnish the supplies or services as described therein. A copy of the contract is attached hereto and made a part hereof.

(b) The ___________ [insert name of subcontractor], hereafter referred to as the subcontractor, agrees and acknowledges as follows:

(1) That it will, for and on behalf of the SBA, fulfill and perform all of the requirements of Contract No. ______ [insert number of contract] for the consideration stated therein and that it has read and is familiar with each and every part of the contract.

(2) That the SBA has delegated responsibility, except for novation agreements and advance payments, for the administration of this subcontract to the Food and Drug Administration with complete authority to take any action on behalf of the Government under the terms and conditions of this subcontract.

(3) That it will not subcontract the performance of any of the requirements of this subcontract to any lower tier subcontractor without the prior written approval of the SBA and the designated Contracting Officer of the Food and Drug Administration.

(4) That it will notify the Food and Drug Administration Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock or other ownership interest to any other party.

(c) Payments, including any progress payments under this subcontract, will be made directly to the subcontractor by the Food and Drug Administration.

2.11 52.219-14 Limitations on Subcontracting (Dec 1996)

(a) This clause does not apply to the unrestricted portion of a partial set-aside.

(b) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for—

(1) Services (except construction). At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.

(2) Supplies (other than procurement from a nonmanufacturer of such supplies). The concern shall perform work for at least 50 percent of the cost of manufacturing the supplies, not including the cost of materials.

(3) General construction. The concern will perform at least 15 percent of the cost of the contract, not including the cost of materials, with its own employees.

(4) Construction by special trade contractors. The concern will perform at least 25 percent of the cost of the contract, not including the cost of materials, with its own employees.

2.12 52.219-17 Section 8(a) Award (Dec 1996)

(a) By execution of a contract, the Small Business Administration (SBA) agrees to the following:

(1) To furnish the supplies or services set forth in the contract according to the specifications and the terms and conditions by subcontracting with the Offeror who has been determined an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(2) Except for novation agreements and advance payments, delegates to the Food and Drug Administration the responsibility for administering the contract with complete authority to take any action on behalf of the Government under the terms and conditions of the contract; provided, however that the contracting agency shall give advance notice to the SBA before it issues a final notice terminating the right of the subcontractor to proceed with further performance, either in whole or in part, under the contract.

(3) That payments to be made under the contract will be made directly to the subcontractor by the contracting activity.

(4) To notify the Food and Drug Administration Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

(5) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the cognizant Contracting Officer under the “Disputes” clause of the subcontract.

(b) The offeror/subcontractor agrees and acknowledges that it will, for and on behalf of the SBA, fulfill and perform all of the requirements of the contract.

(c) The offeror/subcontractor agrees that it will not subcontract the performance of any of the requirements of this subcontract to any lower tier subcontractor without the prior written approval of the SBA and the cognizant Contracting Officer of the Food and Drug Administration.

2.13 52.219-18 Notification of Competition Limited to Eligible 8(a) Concerns (June 2003)

(a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA’s 8(a) Program and which meet the following criteria at the time of submission of offer—

(1) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan; and

(2) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by the SBA.

(b) By submission of its offer, the Offeror represents that it meets all of the criteria set forth in paragraph (a) of this clause.

(c) Any award resulting from this solicitation will be made to the Small Business Administration, which will subcontract performance to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.

(d)(1) Agreement. A small business concern submitting an offer in its own name shall furnish, in performing the contract, only end items manufactured or produced by small business concerns in the United States or its outlying areas. If this procurement is processed under simplified acquisition procedures and the total amount of this contract does not exceed $25,000, a small business concern may furnish the product of any domestic firm. This paragraph does not apply to construction or service contracts.

(2) The ____________ [insert name of SBA's contractor] will notify the Food and Drug Administration Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock or other ownership interest to any other party.

2.14 52.222-42 Statement of Equivalent Rates for Federal Hires (May 1989) In compliance with the Service Contract Act of 1965, as amended, and the regulations of the Secretary of Labor (29 CFR Part 4), this clause identifies the classes of service employees expected to be employed under the contract and states…