SOLICITATION NOTICE
U -- COMPUTER DATA INTEGRITY TRAINING
- Notice Date
- 8/11/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1101264
- Point of Contact
- Vida - Niles,
- E-Mail Address
-
vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35 This announcement constitutes the only solicitation and a written solicitation will not be issued. The synopsis, NAICS code 541690 and 541990, is to notify vendors that the government intends to issue a firm fixed price Purchase Order in accordance with FAR Part 13.106, for the following statement of work, under the simplified acquisition procedures. This solicitation is issued as a Request for Quotes/Proposals STATEMENT OF WORK Computer Data Integrity Training on Data Audit Enforcement BACKROUND 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 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. OBJECTIVE The Office of Compliance seeks to procure the services of a contractor that has proven experience, expertise, knowledge and abilities to provide training to the Office of Compliance staff, especially the Office of Manufacturing and Product Quality and the Office of Scientific Investigations to determine how best to apply the requirements to address data audit integrity, archiving, the 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) or determine if the existing regulations and guidance's need enhancements. This training and collaboration will help shape FDA and industry understanding of electronic data and information, and strengthen compliance and enforcement activities to support public health. The purpose of this document is to describe the activities associated with developing expertise among Office of Compliance staff to understand the requirements to address data audit integrity, data archiving, 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). This would enable the FDA to detect fraud in the use of 21 CFR Part 11, Electronic Records; Electronic Signatures. The FDA investigators need to have necessary expertise and knowledge to have ability to look at data systems and examine them for data manipulation and fraud. SCOPE OF WORK Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities and otherwise do all the things necessary for or incident to the performance of the work described below. The contractor shall provide training and written guidance on various methods for: DECTECTING FRAUD Detecting fraud (Macros, proprietary software, other methods for analyzing data collected from regulated pharmaceuticals manufacturing firms), reviewing analytical data for potential electronic data fraud (e.g. data from spectrometry/chromatography), and methods of collecting data for forensic analysis, in relation to the Office of Information Management (OIM). The contractor shall provide personnel, equipment, supplies, supervision necessary to provide professional training, education, expertise, performance problems, and flaws in medical product and applications relevant to the specific needs of data-integrity and data auditing of computerized systems. KEY STAKEHOLDERS All work shall be performed in accordance with the statement of work and all terms and conditions of this contract. 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. TRAINING MATERIALS The objective of this procurement is to develop and conduct a minimum of eight (8) half day sessions. Computer Data Integrity courses to be held at White Oak campus in Silver Spring Maryland for approximately 15-30 students. The contractor shall generate training material for use at any periodic inspector training sessions provided to Center for Devices and Radiological Health (CDER) Office of Compliance and FDA's Office of Regulatory Affairs. GAP ANALYSIS The contractor shall need to perform a gap analysis to determine if Office of Compliance needs to enhance our regulations and guidances, and assist where needed by providing written technical matter. DETAILED DESCRIPTION OF WORK At a minimum, the contractor shall train OC 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. Train OC Staff how to examine and investigate iSLC methodologies including documentation necessary to support the following key components: A. Project planning for proposed system solutions, definition requirements, scaling, communication plans, deliverables and receivables, B. Project Design: with additional focus on development alignment with existing system architectures, C. Build Phase: coding activities, testing through production qualification specifications and plans for production support, D. Qualification Phase: deployment of test environments, execution of tests, and review of results and acceptance criteria, E. Production and Release: deployment activities related to production environment, F. Compliance review: assessment project activities for adherence to overall plan, STAFF TRAINING A. Train on requirements for electronic records and electronic signatures and/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). This would also include recognizing criteria for handwritten signatures executed to paper copies of electronic records. B. Train how to examine creation and maintenance of an inventory of the systems. C. Train how to review of corporate assessments of systems for Part 11 compliance and evaluate standardized approach to their assessments and evaluate criteria for development/execution of a Part 11 remediation plan for non-compliant systems. D. Train how to evaluate adequacies of incorporating Part 11 compliance when developing/acquiring new systems and instruct how to review internal corporate conduct of Part 11 training. E. Train how to examine software audit trails or in-house database and design of audit Trail. F. Instruct how to examine system validation used in critical tests in a manufacturing laboratory, validation procedure/policy covering computerized analytical data collection and retention systems. G. Instruct how to conduct a review of the validation documentation (such as a protocol and the final report) of one exemplary critical computer system used in the laboratory. H Familiarize the staff with basic concepts of computer system validation that includes the following areas for a more in depth audit: 1. 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. 2. 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. 3. Knowledge 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. 4. Knowledge of how to review change control procedures that are in place and being followed to help ensure that the computer system is kept in a ‘validated state' after the system is validated. commissioned. I. Train staff on 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, evaluation of training records to determine qualified individuals and instruct the staff how to ensure the outsourced electronic data processing conforms to sponsor established requirements. J. Train staff how to examine the maintenance of data security systems, maintenance of security/access level list of individuals who are authorized to make changes and how to examine documentation specifying: a. Permission to enter the location where the archived data is stored b. Record of entry into the archived data location and reason for such entry c. Physical controls used to allow/deny access to this location. d. Encryption practices K. Train staff how to review history and process of data base changes and implementation, understand data transformations, if required by interrelated systems or during data migration. L. Train staff in system security methods, procedures or processes 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. M. Train staff on security topics addressing all appropriate instrumentation within the testing laboratory, including 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). N. Train staff on requirements needed for evaluating retained records and obtain necessary knowledge of documents generated by Analytical Development, Product Development and Quality Assurance departments, to ensure compliance with internal and regulatory agencies. This would include training on how to review adequacy of Work Instructions, SOP's regarding retention schedules, evaluations, archiving, withdrawals, and records destruction. O. Train staff how to evaluate local department adherence to Global Corporate procedures for retention and disposal, including corporate categories and distinctions assigned to vital, essential, operational and other categories. P. Train staff on the procedures/controls that adequately address how the system functions for archiving and retrieval of records, including back-up frequency, location and media. Q. Train staff on 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. R. Train staff to examine iSLC validation processes and adequacy of documentation necessary to support cGLP, cGCO and cGMPs data migrations, corporate knowledge and management of any data transformations, product divestitures or company-to-company data migrations to determine adherence to corporate information systems life cycle (ISLC. S. Train staff to evaluate business agreements and technical documents to support data transfer form contractors to sponsors and review adequacy of gap analysis performed by company for project. T. Train the staff to review Project/Technical Approach to migration. U. Train the staff on practical knowledge of the type of audits: documents, vendor, systems databases, licensing and co-development and instruct the staff on understanding processes for planning, preparing, conducting and reporting of global and local systems audits of processes. V. Instruct the staff how to identify key areas, documentation, 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. W. Train the staff to review chromatography data system (CDS) on critical laboratory instrumentation, such as LC/MS, HPLC, or GC and knowledge how to verify access to the audit trail information for a system that is controlled by the CDS. X. Train staff to examine audit trail functionality in reviewing laboratory data. Y Generate training material and other written matter for use at any periodic inspector training sessions, or to support guidances or policies to enhance inspector/industry understanding of regulatory expectations. QUALIFICATIONS AND REQUIREMENTS The contractor must have documented experience in being able to train 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 would be required. GENERAL QUALIFICATION The contractor trainer shall have the following skill and practical experience: A. Posses thorough understanding of European Union and FDA's Current Good Laboratory Practices (cGLP), Current Good Manufacturing Practices (cGMP) and Pharmaceutical Industry Best Practices B. Expertise in 21 CFR 11 (Part 11) C. Understanding of the technical components needed for a successful data migration D. Specific cGLP and cGMP software and hardware capabilities, including upgrades and integration within corporate system architectures. E. Understand integrity issues for data migration and data management as well as outputs, analysis and reporting derived from such data sources. F. Review adherence to cGXP and internal corporate record retention policies. SPECIFIC KNOWLEDGE OF INFORMATION SYSTEMS LIFE CYCLE (ISLC) METHODOLOGY The contractor trainer shall have the following skills and previous experience: 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 shall be able to conduct of closure activities and evaluate continued production support. SPECIFIC REQUIREMENTS FOR PART 11 cGLP, GCP and cGMP The contractor trainer shall have the following knowledge, which includes advanced understanding from previous experience: The contractor shall 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 shall posses the E.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 shall 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 shall 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(s) shall also have the 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 the familiarity with basic concepts of computer system validation that includes the following areas for a more in depth audit: A. 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. B. 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. C. Knowledge 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. D. Knowledge how to review 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 shall have the following skills and previous experience: 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 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: A. Permission to enter the location where the archived data is stored B. Record of entry into the archived data location and reason for such entry C. Physical controls used to allow/deny access to this location. The contractor shall develop maintenance of SOPs for using these systems, review history and process of data base changes and implementation, and understand data transformations, if required by interrelated systems or during data migration. The contractor shall 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. They shall also 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 shall 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. The contractor shall 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. 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. 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. DATA MIGRATION The contractor trainer shall have the following 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 shall posses 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 shall 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 shall have practical knowledge of the type of audits: documents, vendor, systems databases, licensing and co-development. They shall also posses the understanding for processes, planning, preparing, conducting and reporting of global and local systems audits of processes. They shall 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. They shall 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. GOVERNMENT FURNISH EQUIPMENT AND TRAVEL (a) Provide necessary equipment such as computer and other supplies needed to complete the project. (b) Arrange for office space if needed to complete the project. (c) If travel is required, the Contract Officer Technical (COR) Representative 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 and the government travel per diem. CONTRACTORS ROLES AND RESPONSIBILITIES/STAFFING 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 is responsible for providing personnel with the management, technical and subject matter expertise required to accomplish the activities and prepare the deliverables identified in this Statement of Work. The Contractor shall perform a resume review with the COR or Government designee and may hold interviews in which the COR or Government designee participates. 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. All staff proposed as KEY for this project must be full-time. The contractor will 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 project officer. The Contractor shall propose one or more key person(s), who together, must perform the following role in support of this SOW: CONTRACTOR Responsible for technical and management direction, submission of deliverables, and general support and coordination with the FDA COR 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 Task Order Requirements. The Contractor shall perform project management throughout the life of the contract. TRAINING SPECIALIST Responsible for training FDA staff in evaluating sufficiency of and adherence to corporate information life cycle policies. Responsible for training Agency 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. Additionally, the training specialist would be responsible for instructing our 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. CONTRACT GOVENANCE 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. GENERAL SUPPORT The Contractor shall provide support to 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. DELIVERABLES The Contractor shall be responsible for completion of the following deliverables, including a Gap Analysis and required training materials. : 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 COR. 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. 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. Schedule of Deliverables and Services Due Date After Award/Exercise of Option Task 1: Develop Project Management Plan C.13 Within 10 days of contract award Task 2: Develop Project Work Plan C.13 Within 21 days of contract award Task 3: Conduct Gap Analysis and provide report and conduct a presentation of findings with recommendations Complete by month two and provide two copies to the COR Task 3: Provide Management reports C.13 Monthly and a final yearly report three weeks prior to the end of period of performance Task4: Generate training materials for use during training sessions for a minimum of fifteen FDA staff members Each module developed to be completed three weeks prior to training implementation and submitted to the COR and SME for review Task 5: Provide a minimum of eight (8) Training sessions that support each of the modules for a minimum of fifteen staff members Monthly unless otherwise specified by the COR and technical SME's Task 6: Perform a subsequent gap analysis to determine if OMPQ/DSI needs to enhance our regulations and guidance's. Complete two months prior to the end of the period of performance Task 7: Provide a draft final technical report Two copies due to COR no later than one month prior to the end of the period of performance Task 8: Provide a final technical report Two copies due to the COR one week prior to the end of the period of performance CONTRACTOR REPORTING AND OTHER DOCUMENTATION The contractor shall provide reports to the COR in the following manner: Provide monthly status reports showing: a. The contractor's itemized hours and billing data b. Proposed and approved changes to work assignments c. Staffing issues d. Problems with deliverable schedule e. Status and action plans for any unresolved support issues f. Problems encountered g. Issues requiring FDA management attention PERIOD OF PERFORMANCE The Government anticipates that the period of performance for this contract will be one twelve (12) month award. PLACE OF PERFORMANCE Silver Spring, Maryland. POTENTIAL AWARD WITHOUT DISCUSSIONS The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. In any event, the Government reserves the right to make an award to the best advantage of the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. Technical Evaluation Criteria FDA will evaluate quotes against the following technical evaluation factors: Relevant Experience, Technical Approach, Qualifications of Key Personnel, and Management Plan. The FDA will also evaluate the proposed pricing and past performance. This evaluation will be conducted using a best value methodology. Technical merit will be significantly more important than price in evaluating proposals. FDA will evaluate all price proposals to determine whether the pricing is reasonable; however, the lowest-priced offeror will not necessarily be awarded the contract. In the event that two or more offerors technical proposals are deemed to be of similar merit, price will be the determining factor. Technical Evaluation Factors The relative order of importance of the factors is:  The Relevant Experience and Technical Approach factors are equally rated and of the most importance. Qualifications of Key Personnel and Management Plan/Schedule are of equal importance. 1. Relevant Experience The Offeror's proposal shall demonstrate relevant experience in terms of type, scope, complexity and size on current and previous contracts. The highly rated proposal will also demonstrate the Offeror's ability to produce high quality results on a very tight schedule. 2. Technical Approach This factor considers the Offeror's methodology for accomplishing the work outlined in the SOW. The Offeror's proposal will demonstrate a thorough understanding and clear approach for performance of work resulting from this SOW. FDA will consider: • The Offeror's understanding of the scope and objectives of the subject areas and tasks outlined in the SOW • The offeror's capabilities with respect to the subject areas and tasks outlined in the SOW • The likelihood of success of the technical approach 3. Key Personnel and Management Plan/Schedule This factor considers the education, experience, knowledge and necessary skills of key personnel. The offeror shall provide resumes for the key personnel. The offeror shall indicate how the proposed personnel's experience and knowledge meets the needs and expectations identified in the SOW. The offeror's plans for carrying out all phases of the contract work as it pertains to scheduling work assignments and allocating work resources. The evaluation will assess the appropriateness of the offeror's management plan to the work outlined in the SOW, including (as applicable) methodologies, staffing plan that specifically outlines the estimated level of effort by labor category, preparation, performance measures, management tools, cost control, schedule control, quality control, risk mitigation, and communications will be evaluated. Price Evaluation FDA will evaluate the Offeror's proposed price. The FDA's evaluation of price realism will consider the extent to which proposed pricing indicates a clear understanding of solicitation requirements, reflects a sound approach to satisfying those requirements, and is consistent with the approach described in the offeror's technical volume quote. The price realism assessment will consider technical and management risks identified during evaluation of the quote. Unrealistically low proposed prices (initially or subsequently) may be grounds for eliminating a proposal from competition either on the basis that the offeror either doesn't understand the requirement or has made an unrealistic quote. Past Performance Evaluation The FDA will evaluate past performance as a risk assessment; not as a weighted technical evaluation factor. The Government will assess the relative risks associated with each offer. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror'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 offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror'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 offeror'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 offer. Basis for Award: Award will be made to the party whose quotation offers the best overall value to the Government, technical and price factors considered. The Government will evaluate quotations based on the following evaluation criteria: 1) Technical Approach and Relevant Experience, 2) Qualifications of Key Personnel and Management Plan, and 3) Price. The Technical Approach and Relevant Experience and Qualifications of Key Personnel and Management Plan factors are of equal importance and, combined, these factors are more important than the price factor. If two or more quotations are determined to be approximately equal technically, price may become the determining factor in selecting the awardee. In any event, the Government reserves the right to make an award to the best advantage of the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the purchase order. You may register by going to www.ccr.gov. You will need to your Tax ID, Duns Number, Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later August 15, 2012 4:30 PM EST. QUOTATIONS DUE: All quotations are to be submitted via email to Vida.Niles@fda.hhs.gov, no later than 10:00 AM, EST on August 24, 2012. Responses to this notice shall be sent via email to Vida.Niles@fda.hhs.gov, NO Telephone calls will not be accepted.
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