FDA-SOL-1101268.doc

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Solicitation#FDA-SOL-1101268

PART 1 – DESCRIPTION

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

This solicitation is a Request for Proposals (RFP) using FAR Part 12 & 15 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-58.

This requirement is a Total Small Business Set-Aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 541614 with a Small Business Size Standard of $17 Million. The Government intends to award a purchase order as a result of this solicitation that will include the terms and conditions that are set in PART 3.

PART 2 - SERVICES AND PRICES/COSTS

2. DESCRIPTION OF SUPPLIES & SERVICES

The Center for Drug Evaluation and Research (CDER), Office of Compliance/ Office of Manufacturing and Product Quality (hereinto referred to as “OMPQ”) requires the services of an entity to assess, review and report on best practices in performance excellence/quality management systems in both the pharmaceutical and non-pharmaceutical manufacturing sectors.

2.1. Contract Type: Firm-Fixed Price Purchase Order.

2.2. Pricing Table:

Total

PART 3 – STATEMENT OF WORK

3.1. Objectives:

The OMPQ requires professional support services of those who have proven experience, expertise, knowledge and abilities in the theory AND practice of performance excellence/quality management systems. This experience includes, but is not limited to the following: six sigma, lean manufacturing (and other process improvement methodologies); lean six sigma improvement methodologies; as well as experience in pharmaceutical manufacturing operations; pharmaceutical quality and pharmaceutical senior management practices.

The objective of the assessment is to develop a report based on benchmarking in the pharmaceutical and non-pharmaceutical manufacturing sectors on what an ideal performance excellence/quality management system should look like. The assessment report will describe not only how a firm approaches their manufacturing practice (i.e. Good Manufacturing Practices (GMP’s)), but how they run their overall business in a holistic manner and in a way that ensures they produce high-quality, safe and effective products.

For this contract the OMPQ is aiming to identify best business practices in the pharmaceutical, as well as non-pharmaceutical industries that can be used to define what an ideal pharmaceutical organizational excellence/quality management system should look like. The output will subsequently be reviewed and utilized as a precursor for a formal guidance to the pharmaceutical industry, as well and other outreach activities that would help the FDA get the message out to industry that these ideas are FDA’s current thinking on what a robust pharmaceutical Quality Management System:

· Should be,

· Can be, and should be something that they,

· Should strive to reach, maintain and continually improve upon to make the highest quality, fit-for-use drugs for the public that we serve.

The Malcolm Baldridge Criteria for Performance Excellence is the gold standard for performance excellence criteria (i.e. criteria for a robust QMS) in the world. It is an integrated management framework that has been proven to get positive results. The Baldridge criteria has been benchmarked and utilized in several foreign countries. In addition, the criteria are reviewed annually to make sure they are aligned with best business practices. For the purposes of the contract OMPQ would like the contractor to utilize these criteria when describing best business practices. This will ensure the contractor, the government and the private industry (when OMPQ starts to utilize the study data for outreach) are all “talking” from a standardized set of language.

The overall objectives of this contract is the generation of a report that OMPQ can potentially utilize in the following areas:

1. To set define and set new policy(s).

2. To develop outreach to help educate the pharmaceutical industry on the lessons learned from the study to help them achieve higher, more reliable quality of their products, processes and services.

3. To determine future studies and/or actions that the Agency may want to pursue to continue to advocate for the continued improvement of pharmaceutical quality systems.

3.2. Background:

The pharmaceutical industry has failed to achieve the realization of a six sigma defect rating. The rates of recalls in the pharma industry have remained fairly steady without any significant decrease. Why is this? Why hasn’t the pharmaceutical industry been able to continually improve and realize a six sigma defect rating? What can the pharmaceutical industry do to improve? What does an ideal pharmaceutical organizational excellence/quality management system look like? Answering these questions, and others, are the primary focus of this contract.

3.3. Scope of Work

The scope of this contract is as follows:

Studying no fewer than five (5) non-pharmaceutical firms with highly complex manufacturing operations (ex: semiconductor sector, automotive sector, etc) who have achieved six sigma (or better) defect rates.

Study no fewer than five (5) pharmaceutical manufacturers who are close to a six sigma defect rating. If none can be located, the contractor can substitute firms which appear to have a good compliance history (as Identified by OMPQ) and who possess some of the best practices identified in the non-pharmaceutical sectors.

Comparison and studying:

· The scope of the study is the entire scope of operations. From research and development through product discontinuation (i.e. cradle to grave). OMPQ expects the contractor to look at the entire depth and breathe of the firms operations (research, sales, manufacturing, quality, distribution, etc).

· This report needs to include analyzing levels in results/metrics; the rate/breadth of any data trends; how these levels and trends compare with industry/competitor best practices and how they link it all back to the overall business QMS

· The study should also use the Malcolm Baldridge Criteria for Performance Excellence framework as a guide to identifying best practices.

The FDA will use the results (in the form of a final report) of this study to help determine how a pharmaceutical firm should run their entire business system (from the C-Suite/Executive Offices to the manufacturing shop floor) across the complete drug life cycle.

Specific opportunities that will need to be identified in this study are as follows: How a high performance pharmaceutical firm

· Should best align their inter-related business practices and operations across the organization;

· Can learn from their process, product and service outputs to continually improve their system, and

· Can integrate these learnings back into their organization-wide QMS to continually improve and better deliver a high-quality (fit-for-use) pharmaceutical product to the end patient; and

· Can monitor and utilize the data/results of their processes (process and performance metrics evaluation) to improve their processes, product and services.

3.3. Technical Requirements

The contractor shall perform the following:

3.3.1. Phase 1: Studying/benchmarking in non-pharmaceutical industries: Looking at other complex manufacturing sectors who have realized a six sigma defect rating.

Through this study, the contractor shall identify best practices that could potentially be applicable to the pharmaceutical sector (for example: best practices in equipment, management, culture, processes, etc.);

3.3.1.1. Identify Best Practices

The contractor shall conduct an assessment that will explore the best practices gathered during the benchmarking phase relating to how high performing firms approach, deploy, learn and integrate their “learnings” from their the usage of their processes, products and services based on the core principles of a robust performance excellence/QMS’s including:

· Customer Focus

· Leadership

· Involvement of people

· Process and system approach

· System approach to management

· Continuous improvement

· Factual approach to decision making

· Mutually beneficial supplier relationship

These “best practices” should be described based on their merit (i.e. interconnectivity with other processes within their manufacturing, distribution, sales, and other managerial systems). For example, there are varieties of ways pharmaceutical firms run their formal overall performance excellence/QMS. The gamut runs from formal regulatory requirements to the standard business practices on how they run their internal business processes, practices and services that all have an affect on the interconnectivity with the regulatory requirements. Best practices in these areas that would be optimal starting points include:

· Management Review and oversight of QMS results and how they ensure accountability and oversight of their entire operational unit (very similar to ISO 9001:2008 requirements)

· Corrective and Preventive actions, not only for their formal regulatory requirements, but for the non-regulated parts of their business operations that affect the supply chain decisions, and other areas that would eventually have an impact on the formal regulatory requirements.

· Complaints and Feedback – both the formal complaints and feedback on the regulatory side, but from their “internal customers” to suppliers or raw material consumers (for example an API manufacturer) who provide ideas and complaints on the products and process that should be fixed to improve their QMS.

· Continual Improvement – how these organizations learn from their complaints and feedback process and integrate these “learnings” back into the system to make it more robust, effective and efficient.

· Audits – both internal and supplier audits. Best practices in performing, learning from and incorporating the learning into the processes and procedures to make as fit-for-use products as possible.

· Document Control – how they manage, control and maintain current procedures and the processes they detail.

· Record Control – how they manage, control and maintain current procedures and processes in terms of records developed as product of the processes within the QMS.

· Training and the documentation and maintenance of staff training (including managerial personnel who have oversight of the products, processes and services within the QMS.

· Key performance indicators and other metrics that the firms use to monitor their process performance and how they approach, deploy, learn from and integrate the information back into their business processes, processes and service to continually improve how they run their business.

3.3.2. Phase 2: Studying/benchmarking in the pharma industry: Utilizing the learnings from Phase 1, the contractor shall identify pharmaceutical firms who are close to (or have achieved) a six sigma defect rating. Once in this phase of the contract the goal will be the same as Phase 1 (identify best practices that could potentially be applicable to the rest of the pharma sector). However in this phase, the contractor will need to subdivide the sector into manufacturing type (for example: solid oral dosage form manufacturing versus sterile parenterals manufacturing).

3.3.3. Phase 3: Report Generation: During this phase the study results shall be thoroughly documented and described in detail. The report shall detail: 1) What was accomplished during the course of the study; 2) What was found, (describe why the pharma industry hasn’t obtained a six sigma defect rate yet); and 3) Suggestions for next steps for the OMPQ to execute across the pharma industry.

3.4. Deliverables

The overall deliverable of this contract shall be a formal report that OMPQ and other organizational units within the Center for Drug Evaluation and Research can potentially utilize; the report shall include:

1. The definition of a pharmaceutical best practice (as defined by the contractor, in agreement with the OMPQ).

2. Actual Best practices from the various sectors that were part of the benchmarking study (pharmaceutical and non-pharmaceutical).

3. Recommendations to the OMPQ on next steps and how to roll the study out to the pharmaceutical industry in order to operationalize the findings throughout the industry.

4. A description of an ideal performance excellence/Quality Management System in the pharmaceutical industry.

· The report should describe not only how a firm approaches their GMPs, but how they run their overall business in a way that ensures they produce products that are safe and effective. For example: how does a firm approach their business operations, deploy (and align) their business practices across the organization, how they learn from their process, product and service outputs, and how they integrate these learnings back into the QMS to continually improve to better deliver a high-quality (fit-for-use) pharmaceutical product to the end patient.

· The report should include how high performance pharmaceutical firms use the results of their process (process and performance metrics evaluation) to better their processes, product and services.

· The report shall include looking at levels in results/metrics, the rate/breadth of any data trends, how these levels and trends compare with industry/competitor best practices and how they link it all back to the overall business QMS. Information shall be provided in the report that takes into consideration that the ideal QMS must be sustainable for the firm and not be as stringent as to put them out of business.

Also, the contractor shall be responsible for completion of the following deliverables:

a. Project Management Plan. This plan shall describe the project management processes that organize the work, that ensure project performance information is collected and reviewed and that ensure deliverables are completed on time.

b. Project Work Plan. This work plan shall include milestones, tasks and deliverables.

c. Management Reports. The Contractor shall submit a Monthly Status Report describing the work performed for all tasks and resources expended to date. The report shall provide a written progress report, to include accomplishments, plans, outstanding issues, and an updated project schedule. The Contractor Project Manager shall provide the status report to the FDA Project Officer/Manager.

One copy of each deliverable shall be provided to the FDA Project Manager using email and attachments and in hard-copy form (where applicable), and one copy to the FDA COR using email and/or hard copy form where applicable.

The FDA will accept or reject the deliverables in writing. In the event of the rejection of any deliverable, the FDA Project Manager, giving the specific reason for the rejection, shall notify the Contractor in writing. The Contractor shall have five (5) working days to correct the rejected deliverable and return it to the FDA Project Manager.

3.4.1. Contractor Reporting and Other Documentation

The contractor shall provide reports to the Project Officer/Manager in the following manner:

Provide monthly status reports showing:

· The contractor’s itemized hours and billing data

· Proposed and approved changes to work assignments

· Staffing issues

· Problems with deliverable schedule

· Status and action plans for any unresolved support issues

· Problems encountered

· Issues requiring FDA management attention

3.4.2. Contract Governance Process

This contract shall be managed according to a Project Management Plan (PMP), which shall be created by the Contractor and approved by the FDA. The Contractor shall submit a Monthly Status Report to the FDA Project Officer for review and approval. This report shall be delivered electronically and presented orally at a regularly scheduled project status meeting. This report shall specify:

a. Current project performance.

b. Key accomplishments and problems encountered.

c. Service level, staffing, and price performance (current month and fiscal year to date):

1. Service level performance (planned versus actual).

2. Staffing and expenditures (planned versus actual).

d. Key issues requiring FDA management attention.

e. Productivity recommendations.

f. Proposed and approved work assignments, staffing, deliverable schedule, and any outstanding requirements or issues that need to be addressed.

3.4.3. Schedule of Deliverables

All deliverables are due within a month after award. Each year, after the award of the contract, the Project Officer will develop a specific list of deliverable due dates. The following table identifies deliverables for the contract base period.

3.4.4. General Support

The Contractor shall support the previously defined monthly status meetings. All meetings will be located on FDA property in the DC metro area. The Contractor shall prepare meeting agendas, minutes or notes, issues and action items, distribute meeting documentation, and participate in the dissemination of information regarding the status of the project as outlined in the SOW.

3.6. Place of Performance

Overall execution of this contract, meetings and work sessions, shall be performed at the FDA’s White Oak Campus, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002.

3.7. Period of Performance

The period of performance shall be one year from the date of award.

3.8. Special Considerations

All work shall be performed in accordance with the statement of work, all terms and conditions of this contract and each individual task order. The capabilities required under this contract, include a thorough and comprehensive understanding of the Office of Compliance, its structure, key stakeholders, and the cross over relationships and work process interdependencies between the Office of Compliance, other Offices within the Center, other key stakeholders within Agency and regulated industry.

3.8.1. Detailed Contract Requirements

The contractor shall have documented experience in being able to assess and evaluate quality management systems of pharmaceutical companies.

3.8.2. General Qualifications

The contractor shall have the following skill and practical experience in the following:

Documented understanding of regulatory agency governance including, global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.

Developed and applied elements and requirements of a quality system, evaluate various types of audits and self-inspections, and analyze documents and record management systems.

Experience distinguishing between and verify suitability of factors relating to systems, including relevant compendia for the US, investigations of aberrant results, and record-keeping.

Documented expertise in the tools of Quality Management systems, Quality Models and Theories, Management Elements and Methods, Strategic Plan Deployment, Teams and Team processes, Leadership development and challenges

The Contractor shall perform project management throughout the life of the contract.

PART 4 - INSPECTION AND ACCEPTANCE

4. The Contracting Officer's Representative (COR) will perform inspection and acceptance of services and reports to be provided.

4.1. For the purpose of this PART, (COR - to be determined upon contract award) is the authorized representative of the Contracting Officer.

4.2. Acceptance is communicated in writing unless otherwise indicated in writing by the COR within 30 days of receipt.

4.3. This contract incorporates the following clause, 52.246-4 Inspection of Services-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available.

PART 5 - DELIVERIES OR PERFORMANCE

5. PERFORMANCE

5.1.1. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work in PART 3 of this contract and upon delivery and acceptance by the COR, of the services and reports required at the dates specified within PARTS 3 of this contract.

PART 6 - CONTRACT ADMINISTRATION DATA

6.1. CONTRACTING OFFICERS REPRESENTATIVE (COR)

6.1.1. 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.

6.1.2. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (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.

6.1.3. The contact information for the Contracting Specialist is:

Doreen Williams 5630 Fishers Lane Rockville, MD 20857 Doreen.Williams@fda.hhs.gov

6.1.4. The contact information for the Contracting Specialist is:

William Lee

5630 Fishers Lane

Rockville, MD 20857

William.Lee@fda.hhs.gov;

Tel: (301) 433-5863; Fax: (301) 827-7106

6.1.5. The point-of-contact information for the Contractor is:

Name: (To Be Determined Upon Contract Award)

Email:

Telephone:

6.2. Key Personnel

The Contractor shall designate one or more individuals as key person(s). The Contractor shall guarantee that the FDA will not be without a Contractor key technical or management position, or mutually agreed upon alternate. Any subsequent substitution of personnel shall require express written approval from the FDA.

The Contractor shall propose one or more key person(s), who together, shall perform the following role in support of this SOW:

Consultants and Project Manager – Responsible for technical and management direction, submission of deliverables, and general support and coordination with the FDA Project Officer/Manager and FDA staff, as needed. This individual is fully authorized to direct and supervise day-to-day activities of Contractor and subcontractor staff needed to meet requirements.

Project Manager

Project Consultant

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: William Lee, Contracting Specialist

5630 Fishers Lane

Room 2086, HFA-500

Rockville,MD 20852

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

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

U.S. Food and Drug Administration

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

Address:

Email: XXXXX@fda.hhs.gov *****Acceptable methods of delivery include: mail, hand delivery and email***** B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice Date and Invoice Number;

(III) Purchase order/Award Number;

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

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

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

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

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

(IX) Taxpayer Identification Number (TIN);

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

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

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

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

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

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

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

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

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

MAIL HUB 2145

10903 New Hampshire Avenue

Bldg 32, Rm# 2162, Mail Hub 2145

Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

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

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

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

6.4. Government-Furnished Property

(a) May provide necessary equipment such as computer and other supplies needed to complete the project as appropriate.

(b) Arrange for office space if needed to complete the project.

(c) If travel is required, the project officer will coordinate and assist with the following travel related arrangements for the contractor:

(1) Government travel orders issued for the contractor.

(2) Discuss Arrival and departure times with the contractor prior to making travel reservation. Any changes thereafter will be made by the contractor.

(3) Rental car used must be authorized by the project officer. Rental car reservation will be made by the project officer and must be authorized on the government travel order. The contractor may use personal vehicle and claim mileage at government rates, as indicated on the travel order as long as it does not exceed the government airfare to the training location.

PART 7- Special Contract Requirements

7.1. 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.

7.1.1. Personnel assigned to this contract shall be required to complete 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 and appropriate action taken.

7.1.2. 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.

7.1.3. 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.

7.1.4. 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.

7.1.5. 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.

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

7.1.7. SEQ CHAPTER \h \r 1HHS 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 required 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.

7.1.8. 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.

7.2. Conformance with Applicable Laws, Regulations, Policies, and Standards

7.2.1. Contractor Compliance

The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/.

7.2.2 508 Standard Requirements All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.accessboard.gov/sec508/508standards.htm - Part 1194.

PART 8 - CONTRACT CLAUSES

8.1. 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (Mar 2009) 52.203-5, Covenant Against Contingent Fees (Apr 1984).

52.203-7, Anti-Kickback Procedures (Jul 1995).

52.216-24, Limitation of Government Liability (Apr 1984).

52.233-2, Service of Protest (Sep 2006) 52.243-1, Changes-Fixed Price (Aug 1987) 52.247-35, F.O.B. Destination within Consignees Premises (April 1984)

8.2. FAR CLAUSES BY FULL TEXT

Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (May 2012)

(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:

Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

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

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

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Feb 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

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

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

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

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

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

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

__ (11) [Reserved]

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

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

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

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

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

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637(d)(4)).

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

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

__ (iv) Alternate III (Jul 2010) of 52.219-9.

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

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

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

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

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

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

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

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

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

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

__ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)).

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

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

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

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

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

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

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

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

X (34) 52.222-54, Employment Eligibility Verification (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.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

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

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

__ (ii) Alternate I (Dec 2007) of 52.223-16.

X (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

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

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (May 2012) (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, and 112-42).

__ (ii) Alternate I (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Mar 2012) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (May 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (42) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (45) 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)).

__ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (51)(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.]

__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (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.).

__ (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) (41 351, 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 (Sept 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 (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (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 $650,000 ($1.5 million 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 Veterans (Sep 2010) (38 U.S.C. 4212).

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

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(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.

8.3. HHSAR CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://www.gpoaccess.gov/cfr/index.html.

352.202-1, Definitions (Jan 2006) 352.215-70, Late proposals and revisions (Jan 2006) 352.223-70, Safety and health (Jan 2006) 352.224-70, Confidentiality of information (Jan 2006) 352.228-7, Insurance--Liability to third persons (Dec 1991) 352.232-9, Withholding of contract payments (Jan 2006) 352.233-70, Litigation and claims (Jan 2006) 352.242-71, Final decisions on audit findings (Apr 1984) 352.249-14, Excusable delays (Jan 2006) 352.270-1, Accessibility of meetings, conferences, and seminars to persons with disabilities (Jan 2001) 352.270-10 Anti-lobbying (Jan 2006) 352.270-11 Privacy Act (Jan 2006) 352.270-13 Tobacco-free facilities (Jan 2006)

PART 9 - INSTRUCTIONS TO THE OFFERORS

RESPONSE DATES and TIMES QUESTIONS DEADLINE: All questions shall be received by email William.Lee@fda.hhs.gov before 4:30 pm (1630) EASTERN TIME on 30 July 2012.

RFP Close Date and Time: All proposals shall be submitted via email and be received by 4:30 PM (1630) Eastern Time on 08 August 2012. Late proposals will not be evaluated. Offerors shall ensure the RFP number is visible in the header of the email.

FAR Provision:

52.212-3 Offeror Representations and Certifications—Commercial Items.

An offeror shall only complete paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORA website, the offeror shall complete only paragraphs (c) through (m) of this provision FAR Provisions Incorporated by Reference This contract incorporates one or more provisions 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:

52.212-1, Instructions to Offerors - Commercial Items (June 2008) Proposal Preparation Instructions:

Cover Page:

The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541614; business size; and payment terms.

9.1. Technical Capability

9.1.1. Offeror shall demonstrate they have a documented understanding of regulatory agency governance including: 1) Global Regulatory Framework, 2) Relevant Regulations and Guidelines, and 3) Mutual Recognition Agreements.

9.1.2. Offeror shall demonstrate they have developed and applied elements and requirements of a quality system,…