FBODaily.com | FedBizOpps: PRESOL | R | Computer Data Integrity Training on Data Audit Enforcement - Combined Synopsis/Solicitation

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 23, 2016 FBO #5326
SOLICITATION NOTICE

R -- Computer Data Integrity Training on Data Audit Enforcement - Combined Synopsis/Solicitation

Notice Date: 6/21/2016
Notice Type: Combined Synopsis/Solicitation
NAICS: 541618 — Other Management Consulting Services
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
ZIP Code: 20857-0001
Solicitation Number: FDA-SOL-1163119
Archive Date: 7/16/2016
Point of Contact: Eric Rabinovich, Phone: 2404027631, James G. Whitt, Phone: 2404027627
E-Mail Address: eric.rabinovich@fda.hhs.gov, james.whitt@fda.hhs.gov
(eric.rabinovich@fda.hhs.gov, james.whitt@fda.hhs.gov)
Small Business Set-Aside: Total Small Business
Description: Combined Synopsis/Solicitation PART 1 - DESCRIPTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1163119. This solicitation is issued as a Total Small Business Set-Aside. This solicitation documents and incorporates provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2005-88-1, dated June 15, 2016. The associated North American Industry Classification System (NAICS) Code is 541618 - Other Management Consulting Services; Small Business Size Standard is $15 Million in average annual receipts. The US Food and Drug Administration (FDA) intends to issue a Commercial Item, Firm-Fixed-Price contract that meets the following specifications below. 1.1 Background The requirement for the validation of electronic systems in the regulated pharmaceutical industry brings challenges of how to apply the requirements to preserve integrity of data for manufacturing, testing and laboratory analysis. Audit trails maintain a record of system activity both by system and application processes and by user activity of systems and applications. In conjunction with appropriate tools and procedures, audit trails can assist in detecting security violations, performance problems, and flaws in applications. The Food and Drug Administration (FDA) needs to create a clear approach on where scrutiny and enforcement are needed. The Office of Compliance needs to improve its understanding in how best to regulate electronic records, provide strategies and practical recommendations, including additional guidance and policies that may be needed. 1.2 Objectives The FDA staff must apply requirements to address data audit integrity, data archiving, and the data transfer of information (e.g., transfer of information from electronic health records, data transfer from contractors to sponsors, chain of custody for laboratory contractor). The Office of Compliance seeks to procure services and support to provide tools and techniques that support: (1) Basic and (2) Advance Computer Data Integrity for Data Audit Enforcement learning sessions for FDA staff. 1.3 Scope The Contractor shall provide support for expertise in computer data integrity and data audit enforcement to assist FDA staff in understanding how best to regulate electronic records, provide strategies and practical recommendations, including additional guidance and policies required for the validation of electronic systems in the regulated pharmaceutical industry. The Basic training sessions shall be made up of 7-8 sequential modules over 9 months for 35 in-person staff (each module builds upon the previous module) and the advance training sessions shall be made up of 1 module which spans over a maximum of 4 days each for 50 in person staff. Both training sessions could span over multiple days (not to exceed 4 days) and provide instruction on how best to apply requirements for the validation of electronic systems in the regulated pharmaceutical industry; address data audit integrity, archiving, data transfer of information (i.e., transfer of information from electronic health records, data transfer from contractors to sponsors), and other data integrity issues under current regulations (21 CFR 211.68, Automatic, mechanical, and electronic equipment). PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS The Quoter shall fill out the following pricing sheet: Base Period of Performance: Twelve (12) months from the time of award CLIN Qty Unit of Measure Price Support Services for Expertise in Computer Data Integrity and Data Audit Enforcement 1 EA $ Optional Task: Provide Additional Support of Tools and Techniques 1 EA $ Travel/ODC (Not to Exceed) $10,000.00 Base Period Total: $ Option Year 1 CLIN Qty Unit of Measure Price Support Services for Expertise in Computer Data Integrity and Data Audit Enforcement 1 EA $ Optional Task: Provide Additional Support of Tools and Techniques 1 EA $ Travel/ODC (Not to Exceed) $20,000.00 Option Period 1 Total: $ Option Year 2 CLIN Qty Unit of Measure Price Support Services for Expertise in Computer Data Integrity and Data Audit Enforcement 1 EA $ Optional Task: Provide Additional Support of Tools and Techniques 1 EA $ Travel/ODC (Not to Exceed) $15,000.00 Option Period 2 Total: $ Option Year 3 CLIN Qty Unit of Measure Price Support Services for Expertise in Computer Data Integrity and Data Audit Enforcement 1 EA $ Optional Task: Provide Additional Support of Tools and Techniques 1 EA $ Travel/ODC (Not to Exceed) $15,000.00 Option Period 3 Total: $ Option Year 4 CLIN Qty Unit of Measure Price Support Services for Expertise in Computer Data Integrity and Data Audit Enforcement 1 EA $ Optional Task: Provide Additional Support of Tools and Techniques 1 EA $ Travel/ODC (Not to Exceed) $15,000.00 Option Period 4 Total: $ Grand Total (Base plus Four Option Periods and Optional Tasks) $ PART 3 - TECHNICAL REQUIREMENTS The contractor shall instruct FDA staff on how to examine and investigate integrity issues for data migration and data management as well as outputs, analysis and reporting derived from such data sources; and provide FDA staff instructions on how to examine and investigate Information Systems Life Cycle (iSLC) methodologies, including documentation necessary to support the following key components: • Project planning for proposed system solutions, definition requirements, scaling, communication plans, deliverables and receivables. • Project Design: with additional focus on development alignment with existing system Architectures. • Build Phase: coding activities, testing through production qualification specifications and plans for production support. • Qualification Phase: deployment of test environments, execution of tests, and review of results and acceptance criteria. • Production and Release: deployment activities related to production environment. • Compliance review: assessment project activities for adherence to overall plan. 3.1 The contractor shall work with input from Subject Matter Experts (SMEs) to generate "Basic Computer Data Integrity for Data Audit Enforcement" and "Advance Computer Data Integrity for Data Audit Enforcement" tools and techniques training materials. 3.1.1 The contractor shall update existing training materials for both the Basic and Advance Computer Data Integrity for Data Audit Enforcement training sessions. 3.1.2 The contractor shall provide FDA staff with tools and techniques for evaluating the sufficiency of and adherence to corporate information life cycle policies. 3.1.3 The contractor shall provide materials that demonstrate how to ensure the maintenance of Standard Operating Procedures (SOPs) for using systems, reviewing history and processing of data base changes and implementation, and understanding data transformations, if required by interrelated systems or during data migration. 3.2 The contractor shall deliver (1) Basic and (2) Advance Computer Data Integrity for Data Audit Enforcement sessions that will provide tools and techniques to FDA staff during the base period of performance. The Basic training sessions shall be made up of 7-8 sequential modules (each module builds upon the previous module) and the advanced training sessions shall be made up of 1 module. Both training sessions could span over multiple days (not to exceed 4 days). 3.2.1 The contractor shall instruct FDA staff to detect fraud (Macros, proprietary software, other methods for analyzing data collected from regulated pharmaceuticals manufacturing firms) and review analytical data for potential electronic data fraud (e.g., data from spectrometry/chromatography) and methods of collecting data for forensic analysis. 3.2.2 The contractor shall instruct FDA staff in detecting security violations, performance problems, and flaws in medical product and applications relevant to the specific needs of data-integrity and data auditing of computerized systems. 3.3 The contractor shall provide copies of course materials for each student; course size must not exceed 35 students for each Basic training session and 50 for each Advance training session. 3.4 The contractor, with input from SMEs, shall develop a mechanism to elicit and assess course evaluations. 3.5 The contractor shall ensure the outsourced electronic data processing conforms to sponsor established requirements, maintenance of security systems, and maintenance of security/access level list of individuals who are authorized to make changes by: • Permission to enter the location where the archived data is stored • Record of entry into the archived data location and reason for such entry • Physical controls used to allow/deny access to this location. 3.6 Project Management 3.6.1 The contractor shall develop and maintain a Project Management Plan (PMP) consisting of a minimum of the following elements: Project executive summary, project schedule, change management plan, deployment plan, milestones with estimated completion timeframes, and a project closeout plan. 3.6.2 The contractor, in conjunction with the FDA Project Officer and SMEs, shall establish a schedule for the combined 6-8 classroom courses. 3.6.3 The contractor shall develop and maintain a Project Work Plan which includes, but is not limited to, milestones, tasks, and deliverables. 3.6.4 The contractor shall develop and maintain management reports. The contractor shall submit a Monthly Status Report describing the work performed for all tasks and resources expended to date. The report must include, but is not limited to, a written progress report, accomplishments, plans, outstanding issues, and an updated project schedule. 3.6.5 The contractor shall provide an Annual Report outlining the status of all contract activities and deliverables. NOTE: Course presentations, exercises, handouts, documents or other tangible materials produced by the contractor under this contract must be free of copyrights and be of free domain. 3.7 Optional Task: Provide Additional Support of Tools and Techniques The contractor shall deliver Basic and Advanced Computer Data Integrity for Data Audit Enforcement training sessions (Modules) to FDA staff at a foreign site(s), including, but not limited to, one or more HHS/FDA international offices (i.e. Brussels/London, China, and India). The contractor shall provide up to 2 training sessions (multiple modules) per year per country or region that would encompass 10 days per training session and not more than 2 countries or regions per year. The potential timeframe of these trainings will be timed to optimize local weather conditions and non-holidays, presumably in the Spring/Fall. 3.8 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 COR for review and approval. This report shall be delivered electronically and presented orally at a regularly scheduled project status meeting. This report must 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. The Contractor shall provide support for 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. Section 508 Standards § 1194.21 Software applications and operating systems. (a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually. (b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer. (c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that assistive technology can track focus and focus changes. (d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to assistive technology. When an image represents a program element, the information conveyed by the image must also be available in text. PART 4 - PACKING, MARKING AND SHIPPING All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. PART 5 - INSPECTION AND ACCEPTANCE The Contracting Officer's Representative (COR) will perform inspection and acceptance of deliverables described within Part 3. For the purposes of this PART, (COR - to be determined upon contract award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the locations identified in Part 6. Acceptance will be communicated in writing, unless otherwise indicated in writing by the Contracting Officer or COR, within 30 days of receipt. This contract incorporates the following clause, FAR 52.246-2, Inspection of Supplies-Fixed Price (Aug 1996), as well as FAR 52.246-4 Inspection of Services-Fixed Price (Aug 1996), by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make its full text available. PART 6 - DELIVERIES OR PERFORMANCE One copy of each deliverable shall be provided to the FDA COR using email and attachments and in 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 COR, 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 COR. 6.1 Schedule of Deliveries Task Ref. Deliverables Due Date Deliver To Kick Off Meeting Within five (5) working days of contract award COR and Project Team 3.1 Update training materials for Basic and Advance Computer Data Integrity for Data Audit Enforcement training sessions Each module developed to be completed 60 days after contract award Program POC 3.2 (1) Basic Computer Data Integrity for Data Audit Enforcement training course made up of 7-8 sequential modules (each module builds upon the previous module) As specified in the Project Schedule approved by the COR and technical SME's COR and Program POC 3.2 (2) Advance Computer Data Integrity for Data Audit Enforcement training course made up of 1 module As specified in the Project Schedule approved by the COR and technical SME's COR and Program POC 3.3 Copies of course materials for each student During each scheduled training session as outline in the project schedule COR and Program POC Task Ref. Deliverables Due Date Deliver To 3.4 A mechanism to elicit and assess training evaluations 14 days prior to initial training session COR and Program POC 3.6.1 Final Project Management Plan Within 30 days of contract award COR and Program POC 3.6.2 Schedule for both the Basic and the Advance Computer Data Integrity for Data Audit Enforcement training sessions Within 30 days after contract award COR and Program POC 3.6.3 Final Project Work Plan Within 21 days of contract award COR and Program POC 3.6.4 Management Reports Within 5 business days of the end of previous calendar month; final annual report three weeks prior to the end of the period of performance COR 3.6.5 Final Annual Report Three weeks prior to the end of the period of performance COR 3.7 Optional Task: Course materials; Basic and Advanced Computer Data Integrity for Data Audit Enforcement training sessions (modules); course evaluations; project work plan/reports As agreed upon in the project schedule upon exercise of the optional task COR and Program POC 6.2 Period of Performance: The total period of performance shall consist of a 12-month base period and four (4) 12-month options. The total period of performance shall not exceed five (5) years. Options exercised are contingent upon availability of funds and an acceptable level of performance. Base Period: September 21, 2016 through September 20, 2017 Option Year 1: September 21, 2017 through September 20, 2018 Option Year 2: September 21, 2018 through September 20, 2019 Option Year 3: September 21, 2019 through September 20, 2020 Option Year 4: September 21, 2020 through September 20, 2021 6.3 Place of Performance Work shall be performed at: FDA's White Oak Campus, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 or may be performed at another FDA or HHS recognized government facility, including, but not limited to, one or more HHS/FDA international offices, as follow: New Delhi U.S. Food and Drug Administration Office of International Programs India Office U.S. Embassy Shantipath, Chanakyapuri New Delhi - 110021 U.S. Food and Drug Administration Office of International Programs China Office U.S. Embassy-HHS/FDA #55 An Jia Lou Road Chaoyang District, Beijing 100600, China U.S. Food and Drug Administration Office of International Programs Europe Office Regent Boulevard 40 B-1000 Brussels, Belgium PART 7 - CONTRACT ADMINISTRATION DATA Contracting Officer Representative (COR) The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award) The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. Contracting Officer (CO) 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor of any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The contact information for the Contracting Officer: James G. Whitt 5630 Fishers Lane Rockville, MD 20853 James.Whitt@fda.hhs.gov 240.402.7627 The contact information for the Contract Specialist: Eric Rabinovich 5630 Fishers Lane Rockville, MD 20853 Eric.Rabinovich@fda.hhs.gov 240.402.7631 Quality Assurance - Performance Requirements PERFORMANCE REQUIREMENTS SUMMARY Performance Requirement Performance Indicator Standard Acceptable Quality Level Surveillance Method Training materials developed for Basic and Advance Computer Data Integrity for Data Audit Enforcement Presentations, exercises, handouts, documents and other tangible materials contain pertinent content outlined by OC staff Complete, Accurate, Timely in accordance with requirements 100% complete within 60 days of POED Reviewed by COR or POC Class schedule for both Basic and Advance Computer Data Integrity for Data Audit Enforcement training Documented project schedule for 1) Basic Computer Data Integrity for Data Audit Enforcement training course made up of 8 sequential modules (each module builds upon the previous module) and (2) Advance Computer Data Integrity for Data Audit Enforcement training course made up of 1 module 100% Complete, Accurate, Timely 99% complete within 30 days of POED Inspection by COR or POC Mechanism to assess training evaluations Capability to received feedback for all training sessions 100% Complete and reliable 99% complete within 14 days prior to initial training session Review by COR or POC Project Management activities and documentation Project follows best practices and standards All aspects of the project are included; delivered 30 business days after award date All aspects of the project are included; delivered 32 business days after POED Review by COR and POC Management Reports Includes comprehensive project activities log to date and received by fifth business day of month Reports timely and accurate in accordance with requirements Include project activities logs to date and received within 5 business days of the end of previous calendar month; final annual report three weeks prior to the end of the period of performance Review by COR and POC PART 8 - FAR and HHSAR CLAUSES The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Oct 2015), applies to this acquisition, with the following addenda to the provision: Period for Acceptance of Offers: The Quoter agrees to hold the prices firm through September 30, 2015. See Part 9 for further instructions on submitting a quotation. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Apr 2016), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://www.sam.gov. The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. Upon Acceptance of Deliverables or Monthly Reports, as defined in the contract, the Contractor shall submit invoices to all addresses in the manner specified below: (I) One original and one copy to the approving official: U.S. Food and Drug Administration Office of Acquisitions & Grants Services ATTN: Eric Rabinovich, Contract Specialist 5630 Fishers Lane Room 2139 - HFA-500 Rockville, MD 20857 Eric.Rabinovich@fda.hhs.gov *** ELECTRONIC INVOICES SUBMITTED TO THE CONTRACT SPECIALIST ARE PREFERRED; ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY*** (II) One Copy to the Contracting Officer Representative (COR) or other program center/office designee: (To Be Determined Upon Contract Award) *** ELECTRONIC INVOICES SUBMITTED TO THE COR ARE PREFERRED; ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY*** 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 - SYSTEM FOR AWARD MANAGEMENT) and/or other 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) Contract 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; (c) any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (Must be the same as that in the contract/order award, or in a proper notice of assignment); (VIII) Name, title, and phone number of person to notify in even of defective invoice; (IX) Taxpayer identification number (TIN); (X) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institute receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) Other program center/office point of contact, as references on the contract; (XII) Any other information or documentation required by the contract/order award. Questions regarding invoice payments should be directed to the FDA Payment Office at: ATTN: FDA Vendor Payments Team Office of Financial Services U.S. Food and Drug Administration 10903 New Hampshire Avenue Building 32, Room 2162, Mail Hub 2145 8th Floor, Room 8035A Silver Spring MD 20993-0002 Fax: 866-807-3742 or 301-827-3742 fdavendorpaymentsteam@FDA.GOV FAR 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 at any time within the current period of performance. (End of clause) FAR 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 within 1 day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 1 day before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years, 6 months. The following Health and Human Services Acquisition Regulation (HHSAR) clauses apply to this acquisition and can be obtained at the following website: http://farsite.hill.af.mil/vfhhsara.htm Reg Clause No. Date Clause Title HHSAR 352.203-70 Dec 2015 Anti-lobbying HHSAR 352.208-70 Dec 2015 Printing and Duplication HHSAR 352.222-70 Dec 2015 Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR 352.224-70 Dec 2015 Privacy Act HHSAR 352.227-70 Dec 2015 Publications and Publicity HHSAR 352.233-71 Dec 2015 Litigation and Claims HHSAR 352.239-74 Dec 2015 Electronic Information and Technology Accessibility HHSAR 352.239-73 Dec 2015 Electronic Information and Technology Accessibility Notice HHSAR 352.237-75 Key Personnel (Dec 2015) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty (30) days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. 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, must perform the following role in support of this SOW: Project Manager - Responsible for technical and management direction, submission of deliverables, and general support and coordination with the FDA Contracting Officer Representative (COR), Project Officer/Manager and FDA staff, as required. This individual is fully authorized to direct and supervise day-to-day activities of contractor and subcontractor staff needed to meet contract requirements. The contractor shall perform project management throughout the life of the contract. Subject Matter Expert (Senior) - Responsible for: • Providing FDA staff tools and techniques for evaluating the sufficiency of and adherence to corporate information life cycle policies. • Training Agency staff to detect fraud (Macros, proprietary software, other methods for analyzing data collected from regulated pharmaceuticals manufacturing firms). • Review analytical data for potential electronic data fraud (e.g., data from spectrometry/chromatography) and methods of collecting data for forensic analysis. • Instruct Agency staff to detect security violations, performance problems, and flaws in medical product and applications relevant to the specific needs of data-integrity and data auditing of computerized systems. (End of clause) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2016), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] ___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). ___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). _X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _X_ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note). _X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). ___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. ___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (ii) Alternate I (Jan 2011) of 52.219-4. ___ (13) [Reserved] _X_ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (iii) Alternate II (Mar 2004) of 52.219-7. _X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (Oct 2015) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). _X_ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)). ___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)). _X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). ___ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) (E.O. 13126). _X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). _X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). _X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). _X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). _X_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). _X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627). _X_ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 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) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Oct 2015) of 52.223-13. ___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. _X_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513). _X_ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). ___ (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (43) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (44) 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). ___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). ___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). _X_ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (54) (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) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) ___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). _X_ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658). ___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (10) 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 (Oct 2015) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 $700,000 ($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) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). (ix) 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. (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). (xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 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. (End of Clause) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to "paragraphs (a), (b), (c), or (d) of this clause" in the redesignated paragraph (d) to read "paragraphs (a), (b), and (c) of this clause". Alternate II (Dec 2015). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows: (d) (1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to- (i) Examine any of the Contractor's or any subcontractors' records that pertain to, and involve transactions relating to, this contract; and (ii) Interview any officer or employee regarding such transactions. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than- (i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and (ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (A) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509). (B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (C) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (D) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (E) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (F) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (G) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (H) 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. (I) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (J) ____ (1) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). (K) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). (L) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). (M) 52.222-54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989). (N) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). (O) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (P) 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. PART 9 - BASIS FOR AWARD, QUOTATION PREPARATION INSTRUCTIONS AND EVALUATION CRITERIA It is the Quoter's responsibility to monitor the Federal Business Opportunities internet site for the release of an amendment to the combined synopsis/solicitation (if any). Quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from award consideration. Basis for Award: Quoters are advised that an award of a contract will be made to the vendor whose quotation the Government determines to represent the best value, using the trade-off process and technique, to meet the Government's needs. All evaluation factors, other than cost/price, when combined, are more important than cost or price. However, as Quoters' ratings for non-price factors approach equivalency, price may become more important in the award decision. As quotations become more technically equal, price may take on greater significance in the award decision. The evaluation factors to be used by the Government are described in the subsection entitled "Evaluation Criteria and Basis for Award," below. Quotation Preparation Instructions: All responsible sources may submit a quote, which, if timely received, will be considered. The quote must reference solicitation number FDA-SOL-1163119. The quotes are due in person, by postal mail or email to the point of contact listed below, by no later than July 1, 2016, by 4:30 PM, Eastern Time at the Food and Drug Administration, OO/OAGS, Attn: Eric Rabinovich, 5630 Fishers Lane, Room 2139, HFA-500, Rockville, Maryland 20857. Quoters must ensure the RFQ number is visible in the subject line of the email. Faxed quotes will not be accepted. Late submissions will be treated in accordance with the solicitation provision at FAR 52.212-1(f). For information regarding this solicitation, please contact Eric Rabinovich by phone on (240) 402-7631, or email: Eric.Rabinovich@fda.hhs.gov. Quoters may submit all questions regarding this RFQ to Eric Rabinovich, via email at Eric.Rabinovich@fda.hhs.gov. The FDA must receive the questions no later than 4:30 PM, Eastern Time, Monday, June 27, 2016. The subject line must read: Solicitation No. FDA-SOL-1163119. FDA will not answer questions received after this date and time, and will not answer questions submitted to individuals other than the named contact point (no phone calls, please). RFQ questions and FDA responses will be posted to the Federal Business Opportunities (FedBizOpps) web site. It is the vendor's responsibility to check the FedBizOpps web site for the questions and answers and any other amendments issued for this RFQ. A complete quotation shall consist of a cover letter; Volume 1-Technical Quotation; and Volume 2-Business/Price Quotation. Incomplete quotations will be considered non-responsive and will not be further evaluated. Each volume shall be sent as a separate document. The Technical Portion of the Quotation (Volume 1) and Business/Price Portion of the Quotation (Volume 2) must be kept separate from each other. "Kept separate" is defined as not including any cost/price information in the Technical Portion of the Quotation (Volume 1). The Technical Portion of the Quotation must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. The signature of an official authorized to bind the Quoter shall be placed on each volume. Each volume shall be submitted as follows: Technical Volume: Text color shall be black. Color may be used in graphics or charts for greater clarity at the Quoter's option. Text in graphics and charts shall be no smaller than 9-point; text in tables shall be no smaller than 9-point Arial. The size and font of headers and footnotes are not dictated. No fonts may be condensed. The minimum text size for all other text (text that is not in a table, chart, etc.) shall be 11-point Arial. The Technical Quote is limited to 20 pages. Quoters shall use only 8.5 inch by 11 inch (210mm by 297mm) double-sided paper, single-spaced pages, with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than 9 point. **FDA will not evaluate information submitted over the page limitation** Note: A page in the technical quote that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitation. The following items are not included in the overall 20-page limit: • Cover Page • Table of Contents • Dividers • Resumes (2-page limit) • Contractor Teaming Arrangement (if applicable) • Skill Matrix/Resumes Volume I shall consist of the following: Section I: Technical Approach: The Quoter shall describe its technical approach for meeting the requirements of the SOW. The following information must be included: • A description/narrative that explains your firm's approach for meeting the SOW requirements for Tasks 3.1-3.6. The description must include the Quoter's unique technical approach for providing the required services in the SOW and providing all required deliverables. The Approach must depict the amount of time it will require to provide the deliverable based on the Quoter's technical approach. • The quotation must describe/explain any unique processes or methodologies that will be used to meet the SOW requirements. • The description/narrative must explain any subcontractors or Other Direct Cost item, if any, that the Quoter plans to use in delivering its technical approach. The Quote must identify the specific task where the subcontractors or Other Direct Cost item (without identifying the specific dollar amount) will be used and explain its significance in meeting contract requirements. Ancillary information about your company not directly related to describing your approach for delivering the required services will not be considered. The Quoter's technical approach should not merely offer to conduct the work in accordance with the requirements of the contract's SOW; it must provide a detailed explanation of the Quoter's approach for providing the services. Section II: Expertise and Relevant Experience The Quoter shall describe its knowledge of the subject matter knowledge needed to deliver the services required in the Contract SOW. Specifically, the Quoter shall describe its qualifications and experience related to the following: • Expertise in European Union and FDA's Current Good Laboratory Practices (cGLP), Current Good Manufacturing Practices (cGMP) and Pharmaceutical Industry Best Practices. • Expertise in 21 CFR 11 (Part 11). • Expertise of the technical components needed for a successful data migration. • Experience to recognize upgrades and integration within corporate system architectures. • Experience with integrity issues for data migration and data management as well as outputs, analysis and reporting derived from such data sources. • Expertise in cGXP and internal corporate record retention policies. The contractor shall submit, in writing, all proposed staff (name, resume, title, category, hourly rate, and FDA clearance status) to FDA. The contractor shall identify key personnel in the technical proposal. NOTE: Personnel may not be removed from the task without express approval of the Contracting Officer (CO) or the COR. The Government reserves the right to reject or accept the resume of any employee. The contractor shall provide personnel/staff that is adequately trained and who have attained knowledge necessary for the performance of the client requirements. It is anticipated that contractor employees may have to attend conferences and symposiums to provide interface and attain knowledge necessary for the performance of client requirements. Funding for such experiences will be at the discretion and direction of the FDA COR. Section III: Manpower Staffing and Management: The Quoter shall describe its unique approach for providing manpower and managing the delivery of services needed to meet the requirements of the SOW. • The Quoter shall describe its approach for providing staff to meet the requirements of the SOW. The description shall identify its key personnel staff and provide your firm's explanation of their importance to meeting the requirements of the SOW. • The Quoter shall describe its approach for managing the delivery of service required in this contract. • The Quoter shall provide the resumes of each person that it identifies as key personnel. (See Resume Appendix below for additional instructions.) • As Addendum 2 to the Quoter's Volume 1, the Quoter shall provide descriptions of the labor categories the Quoter will use in the delivery of services required by the SOW. (Note: the labor category description addendum will not count towards the vendor's volume I page count) Resume Appendix (No Page Limit) Resumes must be provided for the key staff proposed only. Resumes are limited to two (2) pages per resume. Resumes should summarize qualifications pertinent to the task the individual is being proposed against. Volume II - Price There is no page limitation to the Price Quote. The Quoter shall complete the pricing information so that the Government can determine: • Price Realism. Price Analysis, in conjunction with Technical Analysis, will be used to perform a Price Realism Analysis to determine if the price is realistic for the work to be performed. The quotation will be evaluated using price analysis techniques to determine whether the proposal reflects a thorough understanding of the SOW, and whether the price proposed is realistic for the work to be performed and is consistent with approaches described in the technical quotation. Price quotations which are determined by the Government to be unrealistically low may be deemed reflective of a failure to comprehend the complexity and risk of the proposed contract, which may be grounds for rejection of the quotation. • Price Reasonableness. Price should also reflect fair market value and be reasonable when compared to the Independent Government Cost Estimate, previous prices for same or similar services and/or when compared among other technically acceptable offers. Additionally: • The Price quote must include price for Manpower Staffing and Management. • The Quoter shall clearly detail all other direct cost, subcontracting prices and travel prices, if any, that comprise the Quoter's price. An item description, quantity and unit price for each shall be provided. • An explanation of any pricing assumption, exception to the SOW or deviation from the SOW must be included in the Price Quotation. • Price Quotations that do not include a detailed price breakdown may be considered non-responsive. The price proposed must be detailed and represent the Quoter's response to the schedule of services above. Quoters are encouraged to include a commercial price list with their quote, as applicable. A Firm-Fixed-Price contract is anticipated, so each Quoter should submit a proposed invoicing schedule showing invoices tied to outputs of value for each period of performance. An acceptable invoice schedule can be tied to a specific milestone plan, individual deliverables, or one final payment upon successful project completion for a given period of performance. Evaluation Criteria and Basis for Award: (a) The provision at FAR 52.212-2, Evaluation-Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government reserves the right to reject any or all quotations received and/or request clarification or modification of quotations, as appropriate. Quotations that are unrealistic in terms of technical commitment will be deemed reflective of an inherent lack of technical competence or indicative of the Quoter's failure to comprehend the complexity and risk involved in the requirements for this contract and will be evaluated accordingly. Each Quoter's technical quotation will be assessed against the technical evaluation sub-factors listed below. During the evaluation of each quotation, separate technical and risk ratings will be assigned for each technical sub-factor. A risk rating only will be assigned for Past Performance, based on the information obtained by the Government on the Quoter's past performance history. Quoters with no past performance history will be judged neither positively not negatively for this evaluation factor. Technical Factor: The technical sub-factors listed below are in descending order of importance. Technical Approach: The Government will assess the vendor's technical approach for meeting the requirements in the SOW, to include any specific processes, methodology for meeting SOW requirements and task deliverables/milestones. Specifically, the Government will assess the Quoter's knowledge and expertise as demonstrated by the following; a. In depth knowledge of Information Systems Life Cycle (ISLC) methodologies including documentation necessary to support the following key components: • Project planning for proposed system solutions, definition requirements, scaling, communication plans, deliverables and receivables, project design: with additional focus on development alignment with existing system architectures. • Build Phase: coding activities, testing through production qualification. Specifications and plans for production support, Qualification Phase: deployment of test environments, execution of tests, and review of results and acceptance criteria, Production and Release: deployment activities related to production environment, and compliance review: assessment project activities for adherence to overall plan. • The contractor shall be able to conduct closure activities and evaluate continued production support. b. Knowledge of specific requirements for Part 11 cGLP, GCP and cGMP. c. Knowledge of Standard Business Agreements between a Vendor and a Firm, or documentation to support cGLP, cGMP Validated activities. d. Documented history of demonstrating record retention under GLP, GCO, and cGMPs. e. Demonstrated skills and previous practical experience to determine adherence to iSLC validation processes and adequacy of documentation necessary to support cGLP, cGCO and cGMPs data migrations. f. Practical knowledge of the type of audits: documents, vendor, systems databases, licensing and co-development. g. Experience in developing and implementing training modules. Expertise and Relevant Experience: The Government will assess the Quoter's knowledge in the development and delivery of services required by the SOW for this contract. Specifically, the Government will assess the Quoter's expertise and relevant experience as demonstrated by the following: Contractor Qualifications and Requirements The contractor must be capable of training personnel on the basic steps of computer forensics as it relates to the preparation (of the investigator, not the data), collection of data, examination, analysis and reporting as it pertains to medical product investigation. Validation of the tools is required. General Qualifications The contractor trainer must have the following skills, which includes advanced understanding from previous practical experience: • Expertise in European Union and FDA's Current Good Laboratory Practices (cGLP), Current Good Manufacturing Practices (cGMP) and Pharmaceutical Industry Best Practices. • Expertise in 21 CFR 11 (Part 11). • Expertise of the technical components needed for a successful data migration. • Experience to recognize upgrades and integration within corporate system architectures. • Experience with integrity issues for data migration and data management as well as outputs, analysis and reporting derived from such data sources. • Expertise in cGXP and internal corporate record retention policies. Specific Knowledge of Information Systems Life Cycle (ISLC) Methodology The contractor trainer must have in depth knowledge of ISLC methodologies, including documentation necessary to support the following key components: • Project planning for proposed system solutions, definition requirements, scaling, communication plans, deliverables and receivables, project design: with additional focus on development alignment with existing system architectures. • Build Phase: coding activities, testing through production qualification. Specifications and plans for production support, Qualification Phase: deployment of test environments, execution of tests, and review of results and acceptance criteria, Production and Release: deployment activities related to production environment, and compliance review: assessment project activities for adherence to overall plan. • The contractor must be able to conduct closure activities and evaluate continued production support. Specific Requirements for Part 11 cGLP, GCP and cGMP The contractor must have the knowledge requirements for electronic records and electronic signatures; demonstrate knowledge of electronic signatures or handwritten signatures executed to electronic records which require certain safeguards due to their unique nature (e.g., appropriate password controls for e-signatures in place). Criteria for handwritten signatures executed to paper copies of electronic records and the creation and maintenance of an inventory of the systems. The contractor must possess the Electronic Review of corporate assessments of systems for Part 11 compliance and evaluates standardized approach to their assessments and the criteria for development/execution of a Part 11 remediation plan for non-compliant systems. The contractor must be able to evaluate adequacies of incorporating Part 11 compliance when developing/acquiring new systems and review internal corporate conduct of Part 11 training. The contractor must have the familiarity with software audit trails or in-house database and design of audit trail, familiarity with system validation used in critical tests in a manufacturing laboratory and familiarity with validation procedure/policy covering computerized analytical data collection and retention systems. The contractor must also have familiarity with review of the validation documentation (such as a protocol and the final report) of multiple exemplary critical computer systems used in the laboratory or manufacturing, and familiarity with basic concepts of computer system validation that includes the following areas for a more in depth audit: • Knowledge on how to examine validation strategy (i.e., how the system needs to be validated and what steps are necessary for the system to be considered validated and commissioned). • Knowledge of how the system will be maintained after being commissioned and how the ‘validated state' will be maintained (includes requirements and procedures for computer specialists, system administrators, users, training, change control, data archival, data backup, system security, access requirements, use of user manuals, etc.). This would include verifying written procedures that define appropriate responsibilities for system administrators and users, verifying procedures are in place for data archival/backup and retrieval, verifying that change control procedures apply to the system and that changes to the system undergo an assessment to determine if the change affects the validated state of the system and verifying training is required before gaining system access. • Knowledge of how to review the system Validation Summary/Final Report), to ensure that the system was accepted and commissioned based on successfully fulfilling the defined requirements that were specified in the validation strategy, including signoffs, and that supporting design documentation is applicable to the version or configuration of a system being evaluated. • Knowledge of how to review that change control procedures are in place and being followed to help ensure that the computer system is kept in a ‘validated state' after the system is commissioned. Knowledge of Standard Business Agreements between a Vendor and a Firm, or Documentation to Support cGLP, cGMP Validated Activities The contractor trainer must be familiar with key aspects of vendor or co-licensing services agreements involving company transfer duties or functions. Implementation of quality assurance and quality control programs with written standard operating procedures and evaluation of training records to determine qualified individuals. The contractor must understand the system security so that only authorized users have access to controlled systems and that specific permissions are assigned to different users types, as appropriate for the work they are required to complete. The contractor must demonstrate knowledge about security topics addressing all appropriate instrumentation within the testing laboratory. This would include procedures/controls available for limiting system access to authorized individuals conducting official business through user's access, controls for unique IDs and password requirements (with automatic time-out feature for locking computer and instructions to log out or lock the computer when leaving the area) Record Retention Under GLP, GCO, AND cGMPs The contractor trainer must have the following skills and previous practical experience: • Understanding requirements needed and adequacy of periodic review/evaluations for retaining records. • Knowledge of documents generated by Analytical Development, Product Development and Quality Assurance departments to ensure compliance with internal and regulatory agencies. • Review adequacy of Work Instructions, SOP's regarding retention schedules, evaluations, archiving, withdrawals, and records destruction. • Evaluate local department adherence to Global Corporate procedures for retention and disposal. • Understand corporate categories and distinctions assigned to vital, essential, operational and other categories. • Possess familiarity with procedures/controls that adequately address how the system functions for archiving and retrieval of records, including back-up frequency, location and media. • Possess familiarity with verification of electronic raw data associated with records that have been archived in the firm's archive system for a chosen system (e.g. HPLC) and are retrievable. Data Migration The contractor trainer must have skills and previous practical experience to determine adherence to iSLC validation processes and adequacy of documentation necessary to support cGLP, cGCO and cGMPs data migrations. The contractor must possess the knowledge to evaluate corporate knowledge and management of any data transformations and to evaluate product divestitures or company-to-company data migrations to determine adherence to corporate ISLC. The contractor must also be able to evaluate business agreements and technical documents to support data transfer form contractors to sponsors, review adequacy of gap analysis performed by company for project, review Project/Technical Approach to migration, and understand the uses of data encryption practices. Audit Processes The contractor must have practical knowledge of the type of audits: documents, vendor, systems databases, licensing and co-development. The contractor must also possess the understanding for processes, planning, preparing, conducting and reporting of global and local systems audits of processes, and must also be able to identify key areas, document any project/product related issues and project/product related data generated by the systems/processes to be audited (e.g., SOPs, guidance documents, study specific procedures, training materials, previous audit reports). The contractor must have familiarity with chromatography data system (CDS) on critical laboratory instrumentation, such as LC/MS, HPLC, or GC and knowledge on how to verify access to the audit trail information for a system that is controlled by the CDS. Knowledge of audit trail functionality in reviewing laboratory data is also required. Manpower Staffing and Management: The Government will assess the Quoter's approach for providing manpower needed to meet the requirements of the SOW, to include the Quoter's approach for providing key personnel and managing the SOW requirements. Price Factor - Price will be assessed for price realism and price reasonableness. Past Performance Past Performance is a risk assessment and is part of the Contractor responsibility determination. The Government will assess the relative performance risks associated with each offer. Performance risks are those associated with a Quoter's likelihood of success in performing the acquisition requirements as indicated by that Quoter's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of a Quoter's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information. When assessing performance risks, the Government will focus on the past performance of the Quoter as it relates to all acquisition requirements, such as the Quoter's record of performing according to specifications, including standards of good workmanship; the Quoter's record of controlling and forecasting costs; the Quoter's adherence to contract schedules, including the administrative aspects of performance; the Quoter's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the Quoter's business-like concern for the interest of the customer. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the Quoter's performance. The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the Quoter. Past Performance Evaluation: The Government will make a past performance determination based on the Quoter's CPARS record. The following ratings will be used to determine the past performance risk rating: Rating Definition High Performance record(s) identify a preponderance of negative reports of past performance. Medium Performance record(s) identify a combination of positive and negative reports of past performance. Low Performance record(s) identify a preponderance of positive reports of past performance. Neutral Little or no relevant performance record identifiable; equates to an unknown risk rating having no positive or negative evaluation significance. The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the Quoter. If a quote is received from a vendor for which the Government cannot find any Past Performance, it will be given a neutral rating. Final Note: This is an open-market combined synopsis/solicitation for services as defined herein. The Government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, ALL quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" The Quoter shall list the exception(s) and rationale for the exception(s). A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful Quoter within the time for acceptance specified in the offer shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Government reserves the right to make an award without communications.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1163119/listing.html)
Place of Performance: Address: FDA White Oak Campus, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN04156199-W 20160623/160621234034-086a9c3b373cbc286c289534273d3840 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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