Sources_Sought_Draft SOW.docx

U.S. FOOD & DRUG ADMINISTRATION (FDA)

CONTRACTOR-HOSTED FULLY INTEGRATED RECORDS FACILITY (FIRF)

INDEFINITE DELIVERY-INDEFINITE QUANTITY (IDIQ)

FDA-SSN-75F40125R00014

TABLE OF Contents

FDA FIRF IDIQ

FDA-SSN-75F40125R00014

DRAFT SOW

U.S. FOOD & DRUG ADMINISTRATION (FDA)

CONTRACTOR-HOSTED FULLY INTEGRATED RECORDS FACILITY (FIRF)

INDEFINITE DELIVERY-INDEFINITE QUANTITY (IDIQ)

DRAFT STATEMENT OF WORK (SOW)

INTRODUCTION

The mission of the Food and Drug Administration (FDA) is to protect the health of the American public (www.fda.gov). For more than one hundred (100) years, FDA has been the international leader ensuring safe food, cosmetics, human drugs, biologics, veterinary products, medical and radiological devices, and tobacco products. As part of its mission, the FDA receives documents from a variety of public and private entities, including regulated industry. Throughout FDA’s history, document control and records management has played a vital role in the Agency’s regulation process and, ultimately, in the mission to protect public health. This allows FDA to comply with federally mandated document control and record keeping requirements, while maintaining a high level of accountability to the citizens of the United States. To ensure proper organization and management of documents and records materials, the FDA complies with regulations set forth in the Federal Records Act per United States Code (U.S.C.), Title 44, Chapters 29 thru 33; Title 36 Code of Federal Regulations (CFR), Chapter 12; and National Archives and Records Administration (NARA) guidance.

BACKGROUND

Document control and records management practices are exercised throughout the FDA. This contract encompasses processing documents and records material related to scientific advancement and public health issues at the Fully Integrated Records Facility (FIRF). Due to business strategic initiatives for managing documents and records material, FDA has an ongoing need for flexible accommodations/infrastructure for processing documents and records material.

The FDA regulatory mission supports many laws and Federal regulations that give FDA its mandate. This includes, but is not limited to, Federal Food, Drug and Cosmetic Act, Food and Drug Administration Amendments (FDAAA), Food and Drug Administration Safety and Innovation Act (FDASIA), and other relevant statutes, as follows: Prescription Drug User Fee Act (PDUFA), Medical Device User Fee and Modernization Act (MDUFMA), Clinical Laboratory Improvement Amendments (CLIA), Medical Device Amendments, Safe Medical Devices Act, Electronic Product Radiation Control Provisions of the Food Drug and Cosmetics Act (formerly the Radiation Control for Health and Safety Act), Biosimilar User Fee Act (BsUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), Mammography Quality Standards Act (MQSA), Export Reform and Enhancement Act (EREA), Freedom of Information Act (FOIA), Family Smoking Prevention and Tobacco Control Act (FSPTCA), and Food Safety Modernization Act (FDMA).

The FDA is required by law to regulate the cosmetic, pharmaceutical, food, and medical device industries. Regulatory Submissions are applications submitted by industry that describes the content and use of products and requires approval from the FDA before being marketed to the public.

Regulatory submissions vary across Centers, but typically fall in one of the following categories: pre-market or post-market. Pre-market submissions include pre-application materials, investigational applications, new product applications and license applications. Post-market submissions include supplemental applications to marketed products, adverse event reporting, registration and listing information, export applications and certificates, and promotional materials. For more detail regarding specific regulatory submissions and associated forms, see the following hyperlink: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.

The FDA creates and receives a variety of non-regulatory Federal records. This includes, but is not limited to, program records, office administration records and dockets.

DOCUMENT/RECORDS MANAGEMENT TECHNICAL ENVIRONMENT

FDA’s Document Control Centers (DCC) ensure timely receipt, processing, temporary storage, and distribution of applications to the FDA reviewer community. Currently, there is an off-site Contractor-hosted DCC. This DCC provides full life cycle records operations and support.

FDA desires to further the cost savings and better able strategical response to Agency space constraints through the consolidation of like functions performed by contractors supporting the off-site Contractor-hosted DCC. This type of work environment provides FDA with increased flexibility regarding managing space constraints to achieve cost savings.

The FDA DCC processed over 3,529,079 paper and electronic application submissions in Fiscal Year (FY) 2024. Each application submission may have multiple record keeping transactions (e.g., document preparation, imaging, login, hold, amendments, log out, and issuance of correspondence for purposes of gathering additional information to support or close the review). Therefore, the number of transactions will be substantially greater than the number of unique application submissions.

The FDA receives materials from sources internal and external to the agency, which includes, but is not limited to, paper and electronic. Materials include documents, letters, memoranda, completed forms, statistical and narrative reports, URLs, graphics, photographs, audio and video recordings, diskettes, DVDs, CDs, microfiche, microfilm, and USB drives. In addition, FDA receives physical artifacts such as labels, bottles, syringes, laboratory samples, feed bags, and boxes.

In addition, some Centers accept electronic copies (eCopies). An electronic copy (aka eCopy) is an exact duplicate of a paper submission, created and submitted on a CD or DVD, or electronically through the electronic submissions Gateway, accompanied by a copy of the signed cover letter and the complete original paper submission.

21st CENTURY ELECTRONIC BASED RECORDS INFORMATION MANAGEMENT (RIM) ENVIRONMENT

The FDA strives towards a streamlined 21st Century electronic Records Information Management (RIM) Lifecycle environment that preserves the integrity of public records while creating cost efficiencies that allows the Agency to focus on advancing in scientific and public health efforts. FDA recognizes that electronic submissions have many advantages over paper submissions. By storing electronic submissions in Electronic Document Rooms (EDRs) they are readily accessible to reviewers at all times. The FDA’s goal is to be 100% electronic.

Currently, FDA receives electronic submissions in a structured format for regulatory submissions. Cosmetic, pharmaceutical, food, and medical device or electronic product regulatory submissions, which are applications submitted by industry, or other regulated industries provide required information to the FDA to comply with the regulations for regulated products. Regulatory submissions vary across Centers, but typically fall into one of the following categories: pre-market or post-market.

PURPOSE

The purpose of this Indefinite Delivery-Indefinite Quantity (IDIQ) contract is to obtain Contractor services related to several document control and records related activities throughout FDA, to be performed at the Contractor’s FIRF. This includes receiving, processing, inventorying, scanning services, disposing of documents and records materials, cataloguing, storage of documents, materials, redaction, data entry, helping firms with submitting information electronically, running reports/queries, correcting, and entering data into electronic systems and emailing correspondence to firms.

OBJECTIVES

The FDA has several business objectives for the processing of documents, records material and information, such as:

SCOPE

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and facilities to do all things necessary for or incident to the performance of the work for Contractor-hosted offsite document control services. The Contractor shall be responsible for complete management of the FIRF in which services are provided.

TASKS AREAS

The FDA Off-Site regulatory document and records control and electric submissions handling processes are divided into the following major task areas:

Task Area 1: Program and Task Order Management Support;

Task Area 2: Document Processing, Handling, Correspondence, and Delivery;

Task Area 3: Document Scanning, Photocopying, Conversion, and Premarket Services;

Task Area 4: Document Data Entry Services, Data Analysis, Tracking Services, and Stakeholder Support;

Task Area 5: Tracking and Temporary Storage of Government Records; and Task Area 6: Transition Work Activities

TASK AREA 1: PROGRAM AND TASK ORDER MANAGEMENT SUPPORT

The Contractor shall provide the program management services necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all delivery orders or task orders (DOs/TOs) and activities throughout the IDIQ contract’s period of performance. The Contractor shall provide both Contract-Level Program Management task support and TO-level project management task support to establish control, management, monitoring, and notification mechanisms, and shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR) and Subject Matter Experts (SMEs) to ensure that tasks stay on track and important milestones are met. As such, this may require the Contractor to hire multiple supervisors to oversee a variety of functional work activities, as necessary, to ensure performance standards will be successfully completed.

Representative activities include, but are not limited to:

· Administer the IDIQ contract;

· Develop, maintain, modify, and update plans throughout the period of performance to include: DO/TO communication plan, quality assurance plan, quality control plan, training plan, transition plan, contingency plan, staffing plan, and Standard Operating Procedures (SOP);

· Prepare, as requested, a Task Order Management Plan (TOMP) for each DO/TO describing the technical approach, organizational resources and management controls throughout DO/TO execution.

· Develop Program Management Plan (PMP);

· Prepare monthly progress and financial reports;

· Establish notification mechanisms for acceptance by the FDA

· Comply with reporting requirements, as tasked;

· Follow escalation procedures for problems, issues, and recommendations, as tasked;

· Respond to FDA staff and industry questions regarding status of submissions;

· Safeguard information;

· Manage Contractor staff and provide subcontractor management;

· Ensure proper exit criteria are followed when Contractor employees leave projects;

· Provide risk mitigation;

· Conduct and participate in progress meetings, facility meetings, training meetings, performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, and COR site visits, and post requirements meetings; and,

· Respond to ad hoc data calls.

TASK AREA 2: DOCUMENT PROCESSING, HANDLING, CORRESPONDENCE, AND DELIVERY

Documents and records material shall be received at the FIRF. The Contractor shall receive U.S. Mail and deliveries via commercial, private couriers, and may also receive electronic documents e.g. via email or other mechanisms that require processing. Specific mail room processes will be identified in the individual TOs. The Contractor shall be required to staff the mail room, monitor electronic document systems, including emails, sort documents received, prioritize, triage, scan, bar-code/track, and distribute both hard copy and electronic regulatory submissions to the FDA community, or coordinate with U.S. mail couriers and others. The Contractor shall be responsible for tracking all documents to and from their FIRF and the FDA White Oak campus.

As tasked, the Contractor shall process required and voluntary eCopies of submissions provided to FDA on an electronic media (e.g., CD) into the official repository.

The Contractor shall process each submission type according to priorities defined by the Center for Devices and Radiological Health (CDRH). Priorities may change over time at the discretion of the FDA based on the needs of the program and to satisfy any regulatory changes.

The FDA creates and receives a variety of non-regulatory Federal records. This includes, but is not limited to, program records, office administration records, and dockets. The Contractor shall provide user support services to internal and external stakeholders. Some examples of user support services are: responding to inquiries regarding the status of documents being processed, assisting firms with entering data into an electronic system to comply with regulatory requirements and searching for records to respond to Freedom of Information Act (FOIA) requests.

In addition, but not limited to, the Contractor shall perform tasks related to document and records information processing. As tasked, the Contractor shall provide courier service to multiple FDA facilities each weekday. The Contractor shall be responsible for providing courier services and distributing mail and stored files between off-site and on-site locations and coordinating pick-up and drop-offs as identified in individual TOs. The FDA distributes documents and records materials to FDA employees, managers, and Contractor staff. New incoming regulatory submissions are primarily distributed to the FDA reviewer community. Non-regulatory material may go to the FDA reviewer community, Contractor staff, administrative staff, and program managers, as needed/or instructed. Distribution locations can be modified or changed throughout the review process for various reasons; thus, requiring data entry changes in the applicable tracking system. The Contractor shall also provide expedited delivery services of FDA materials. Expedited delivery is within one (1) to two (2) hours of an order being placed. The Contractor shall deliver records materials after hours, as required. After hours are after normal business hours (8:00 am – 5:30 pm) Monday through Friday, weekends, and holidays. The Contractor shall be responsible for providing back-up couriers/drivers services in the event courier support services are required after hours.

TASK AREA 3: DOCUMENT SCANNING, PHOTOCOPYING, CONVERSION, AND PREMARKET SERVICES

The Contractor shall perform off-site scanning services, which may range from digitizing legacy material to processing new physical documents and records material. The majority of scanned services shall be paper to electronic images. The Contractor shall also convert material such as film, videos, microfiche, blowbacks, and physical artifacts into digitized images.

In addition, the Contractor shall provide assistance with scanning PreMarket documents to include routine scanning of paper submissions, historical paper copy submissions and microfiche submissions. For historical copies and microfiche submissions, the Contractor will first verify whether the submission is loaded into IMAGE. If the submission has not been loaded into IMAGE, the Contractor shall scan the submission and perform a QC on the images to ensure the quality and accuracy of the scans. Once the submission has been verified in IMAGE, the contractor shall destroy the documents immediately.

Requirements for off-site scanning, photocopying, conversion, and PreMarket services will vary from Center to Center and will be outlined in the individual TOs. Generally, the Contractor shall:

· Coordinate and track drop-off and pick-up;

· Prepare physical documents/files for imaging documents/files;

· Provide duplicate copies of submission as requested by authorized officials;

· Provide photocopying services;

· Provide methodology for digitizing images other than paper such as oversized material and physical artifacts;

· Provide image standards for black & white or color will be a minimum of 300 Dots per Inch (DPI). Images will adhere to formats (PDF, PDF/a, TIFF, etc.);

· Process images for Optical Character Recognition (OCR);

· Re-assemble documents/files to the pre-image condition;

· Index images in specific FDA tracking systems, which may include internal FDA mailboxes and systems;

· Load images to a FDA electronic records repository or copied to other media;

· Complete various quality control checks throughout the imaging process ensuring consistent image capture, indexing and repository upload/media transfer;

· Load verification of submissions into IMAGE, and reload submissions if necessary;

· Perform QC of loaded submissions for accuracy; and,

· Destruct documents after loading into IMAGE

TASK AREA 4: DOCUMENT DATA ENTRY SERVICES, DATA ANALYSIS, TRACKING SERVICES, AND STAKEHOLDER SUPPORT

The Contractor shall be responsible for using a database system (i.e., a combination of FDA existing systems and the Contractor’s system which will be used to determine where a document is located at any given time) to conduct scheduled inventories of documents and records located at FIRF and to track the real-time file movement (and status of files) between FDA on-site and off-site locations. FDA Document and Records Managers need access to the inventory data which allows FDA to track the location of documents and determine the status of documents (e.g., change status of files from active to inactive). As tasked, the Contractor shall upload inventories of documents and records information into Center-specific tracking systems and databases.

In addition, the Contractor shall perform the following tasks related to document and records information processing:

· Conduct Document Quality Control (QC) to ensure all aspects of processing are accurate, consistent, and complete;

· Upload scanned files into the appropriate FDA Electronic Document Room or Tracking System;

· Apply proper information security access controls;

· Prepare and enter metadata elements into information systems;

· Conduct data abstraction;

· Code and index submittals;

· Correct data entry errors;

· Respond to and resolve to stakeholder (e.g. industry and FDA staff) inquiries / questions regarding regulatory document and electronic submissions;

· Provide stakeholders assistance in submitting electronic information;

· Provide stakeholders assistance in complying with submission requirements;

· Resolve issues related to document control functions for regulatory submissions;

· Participate in user acceptance testing on records systems upgrades;

· Assigning user roles and responsibilities as directed by records managers;

· Perform redaction of submittals;

· Ensure new records management software solutions have backward compatibility;

· Automate records schedules;

· Monitor storage availability;

· Organize and cleanup of electronic copy records;

· Conduct scanning activities;

· Send paper-based submissions (i.e. those that do not require an eCopy) to be scanned into the official repository, as tasked

· Upload electronic data into Center repositories

· Perform data entry/processing demonstrations

TASK AREA 5: TRACKING AND TEMPORARY STORAGE OF GOVERNMENT RECORDS

The Contractor shall be responsible for notifying the IDIQ COR, DO/TO COR/Task Order Project Manager (TOPM), and Center’s Records Manager when the Records Control Schedules (RCS) indicate a file is ready for retention and/or disposal. The Contractor shall obtain written authorization from the Center’s Records Manager before moving or disposing of files. The FDA classifies retention and disposal schedules by the following record types: administrative, program, or Center-Specific. The Agency regularly analyzes, develops, produces, and updates FDA RCS(s) for the Agency, as well as for the individual Centers.

Contractor representative tasks shall include:

· Adhere to retention and disposition schedules as part of identifying files to be cataloged, temporary stored and/or disposed;

· Support off-site storages programs, including the Federal Records Centers, FRC System, and Agency approved commercial storages vendors;

· Provide temporary storage periods which range significantly and will be contingent on the types of document and records;

· Dispose of records material by prepping documents for disposal, coordinating with disposition Contractor for drop off and pick up, shredding and / or coordinating with shredding Contractor, donation, and accession of records to another FDA approved facility;

· Provide certificates of destruction at the request of FDA TOPM;

· Update the inventory of documents and records accordingly on a real-time basis; and,

· Transfer closed files to the Federal Records Center or a NARA approved commercial storage facilities.

TASK AREA 6: TRANSITION WORK ACTIVITIES

Transition activities shall take place to efficiently transition DO/TO requirements from the predecessor Contractor to the Contractor, if necessary, and from the Contractor to the successor Contractor upon the completion of this contract, if necessary. As tasked, the Contractor may be required to develop transition-in and transition-out plans for individual Dos/TOs issued against this IDIQ contract based on individual requirements.

TRANSITION-IN

A smooth and orderly transition-in among the Contractor or FDA and the predecessor contractor is necessary to ensure minimum disruption to vital FDA business. Transition-In Plans shall include, at a minimum, a description of parallel operations, management plans, personnel on-boarding process tracking, and an updated list of Contractor personnel, with anticipated start dates and responsibilities. The Contractor shall cooperate fully in transition activities. The Contractor shall work with the FDA Help Desk Support during transition to implement the Help Desk Support Project Plan for any large-scale relocation/movement of equipment. This shall include, but may not be limited to, the relocation/movement of FDA IT computer equipment, such as computer monitors, keyboards, mice, laptop and desktop computers, printers, scanners or any other peripherals.

TRANSITION-OUT

A smooth and orderly transition-out between the Contractor, FDA, and the successor contractor is necessary to ensure minimum disruption to vital FDA business. The Contractor shall be required to submit and execute a Transition-Out plan to ensure business continuity for the FDA in the event there is a successor Contractor. This shall include, at a minimum, the following:

· Transition-Out Plan and Schedule;

· Scheduling of knowledge walkthrough sessions;

· Providing “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor;

· Submitting knowledge transfer documentation, to include current and up-to-date Standard Operating Procedures (SOP’s);

· Providing FDA with current inventory of all Government-owned assets used by the Contractor, along with full support in the reconciliation of this inventory.

To accommodate strategic initiatives for creating cost and operational efficiencies, the FDA anticipates DCC locations and housed documents may change between various locations during the life of this IDIQ contract. As tasked, the Contractor shall assist with the preparation and movement of documents between current facilities and new or existing sites. This shall occur in the event new facilities are set up. The FDA may continue consolidation efforts towards a centralized DCC to house all FDA’s documents and records materials. In addition, the Contractor shall be required to develop and adhere to security procedures and transition plans in support of document relocations. The Contractor shall be required to manage documents and other submissions in a timely and secure manner during day-to-day planned activities and facility relocation in accordance with FDA processing guidance and policies.

FACILITY REQUIREMENTS

INFRASTRUCTURE AND EQUIPMENT REQUIREMENTS

All infrastructure must obtain an Authorization to Operate (ATO) certificate from FDA, which certifies the FIRF and IT equipment that are proposed to process FDA’s documents are compatible with FDA’s physical and logical environments.

All Contractor-provided equipment connected to FDA’s network must be isolated for FDA business exclusively and may not be used to process any non-FDA business. Therefore, the FDA technical environment must be separated from the Contractor’s internal technical environment.

FDA DIRECT DATA CABLE

Upon award of the first DO/TO issued under this IDIQ contract, the Government will be responsible for purchasing, installing, and maintaining a Verizon data cable line that directly connects from the FDA White Oak Campus to the Contractor’s facility.

The Contractor shall safely conceal data outlets, and the associated wiring used to transmit data to workstations must be in floor ducts, walls, columns, or below access flooring. The Contractor shall provide outlets, which must include rings and pull strings to facilitate the installation of the data cable. When cable consists of multiple runs, the Contractor shall provide ladder-type or other acceptable cable trays to prevent Government-provided cable from coming into contact with suspended ceilings or sprinkler piping. Cable trays must form a loop around the perimeter of the Government-demised area such that they are within a 30-foot horizontal distance of any single drop.

OFF-SITE FACILITY MANAGEMENT

The FIRF must comply with Federal Information Security Management Act (FISMA) and supplemental policies for securing document and records material and information.

The Contractor shall comply with all Federal, state and local laws, codes and ordinances applicable to use and occupancy of Real Property, including, without limitation, laws applicable to the construction, ownership, alteration, maintenance or operation of all buildings, structures, and facilities located thereon, and obtain all necessary permits, licenses and similar items at its own expense. This contract shall be governed by Federal law.

REGULATORY REQUIREMENTS

Compliance with the Occupational Safety and Health Act (OSHA) and other applicable laws and regulations for the protection of employees is exclusively the obligation of the Contractor, and the Government will assume no liability or responsibility for the Contractor's compliance or non-compliance with such responsibilities.

FDA Security Authorization Process is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the confidentiality, integrity and availability of information collected, processed, transmitted, stored, or disseminated by the Agency.

The Contractor’s FIRF must meet all of the standards in 41 CFR, Federal Property Management Regulation (FPMR) 101, American Society of Hearing, Refrigerating and Air-Conditioning Engineers (ASHRAE), Occupational Safety and Health Administration (OSHA), and applicable County and State Codes.

National Institute of Standards and Technology (NIST) SP800-53 – This publication was developed by the Joint Task Force Transformation Initiative Interagency Working Group with representatives from the Civil, Defense, and Intelligence Communities in an ongoing effort to produce a unified information security framework for the federal government— including a consistent process for selecting and specifying safeguards and countermeasures (i.e., security controls) for federal information systems. (See SP 800-53 Rev. 3: Recommended Security Controls for Federal Information Systems and Organizations.)

Federal Information Security Management Act (FISMA) - The E-Government Act of 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of the E-Government Act, known as FISMA, states that effective information security programs include:

· Periodic assessments of risk;

· Policies and procedures that are based on Risk Assessments (RA), cost- effectively reduce information security risks to an acceptable level, and address information security throughout the EPLC;

· Plans for providing adequate information security for networks, facilities, Information Systems, or groups of Information Systems, as appropriate;

· Security awareness training to inform personnel;

· Periodic testing and evaluation of the effectiveness of information security policies, procedures, practices, and security controls to be performed with a frequency depending on risk, but no less than annually;

· A process for planning, implementing, evaluating, and documenting remedial actions to address any deficiencies in the information security policies, procedures, and practices of the organization;

· Procedures for detecting, reporting, and responding to security incidents;

· Plans and procedures for continuity of operations for Information Systems that support the operations and assets of the organization.

NIST - The E-Government Act (Public Law 107-347) recognized the importance of information security to the economic and national security interests of the United States. Title III of FISMA, included duties and responsibilities for the Computer Security Division in Section 303 of the NIST document.

PHYSICAL ACCESS CONTROLS

Entrance into the Contractor’s FIRF must be through controlled entry point(s). Visitors shall be required to sign in and out at the entrance and state the purpose of their visit. A log shall be kept of all such visits. Persons that do not have a legitimate business need related to the facility operation shall not be allowed access to the FIRF.

NETWORK ACCESS CONTROLS

Contractors accessing FDA’s Virtual Private Network (VPN) from off-site locations to manage records information must be connected to the Network through an FDA authorized secure channel, such as Cisco AnyConnect/Zscaler. All Contractor staff accessing FDA’s network from remote locations are subject to FISMA regulations. The FDA reserves the right to inspect the FIRF to verify FISMA compliance. Please note, Contractor staff may not access the network via their personal computers. If a direct connection is required from the FIRF to the FDA network due to bandwidth or security reasons, the Government will provide the Contractor with all necessary specifications for the Contractor to provide proper connectivity.

KEY PERSONNEL

The Contractor shall provide sufficient personnel possessing the skills, knowledge, training, and security clearances to perform the services required by this IDIQ. The Government requires a balanced team of personnel to ensure operational (budgetary/financial) and technical aspects of the IDIQ are successful.

In accordance with HHSAR 352.237-75, Key Personnel, the following are the anticipated key personnel:

Program (Contract) Manager

It is critical that the Contractor is committed to maintaining consistency in key personnel and staff assignments for the duration of the planned system implementation.

The Contractor shall ensure that personnel maintain generally required professional certifications, accreditations, and proficiency relative to their areas of expertise (as defined in the labor category description of the IDIQ). Training of contractor personnel to fulfill these requirements shall be performed at the Contractor’s expense. The Contractor shall retain documentation of such records.

Additional key personnel may be identified within each individual DO/TO.

LABOR CATEGORY DESCRIPTIONS

The staff for each DO/TO will include positions selected from the following labor categories. Not all categories may be used for each DO/TO. By mutual agreement by the Contractor and the Government, additional labor categories may be added at a later date to the schedule.

Analyst Coder I

The Analyst Coder I shall have a Bachelor’s degree or higher (preferred but not required) in related health science, such as physicians, nurses, pharmacists, veterinarians, and/or certified/licensed technicians, as appropriate for each center. Education/experience can be combined to satisfy the requirement. Ensures the accuracy of data entered into critical fields according to the Standard Operating Procedures (SOPs); performs data entry functions as needed; and provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors. Experience in using advanced software systems to resolve and handle medical coding of adverse event forms using coding terms. Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures in each center. Resolve problems related to data entry.

Analyst Coder II

The Analyst Coder II shall have a Bachelor’s degree (Master’s degree preferred but required) in related health science fields such as Nursing, Pharmacy, Veterinary, and/or Doctorate in Medicine, as appropriate for each center. Education/experience can be combined to satisfy the requirement. The Analyst Coder II must meet all the qualifications of the Analyst Coder I, as well as being able to perform the following duties: ensures the accuracy of data entered into critical fields, per coding principles and procedures and the Standard Operating Procedures; performs coding in accordance with the FDA instructions for coding and ICH Coding Principles for documents, and include quality control and quality assurance procedures to ensure appropriate selection of codes; performs data entry functions as needed; provides quality assurance of the entered data providing critical feedback to data entry staff using a database designed to capture, track, and report errors; and attends team meetings and training sessions. Experience and proficiency in the use of advanced software systems to resolve and handle medical coding of adverse event forms using coding terms. Experience in coding Individual Case Safety Reports (ICSRs) according to appropriate taxonomies, and established policies and procedures in each center. Possess at least 2 years of managerial experience. Interface with internal users as well as external stakeholders. Apply and use project management tools such as MS Projects, spreadsheets, etc. Use and direct personnel to code from Adverse Event Report forms or images of these forms into a relational database using International Medical Terminology; verify medical code and data entry. Review and retrieve system data, match output with specifications in accordance with Standard Operating Procedures and resolve discrepancies. Manage functional task activities and lower level personnel.

Document Imaging TechNICIAN

The Document Imaging Technician shall have a high school diploma or equivalent. Must have one (1) year health information management or clerical experience with at least six (6) months in a healthcare setting. Basic computer skills and experience required. Ability to examine the record and verify patient identification using multiple systems and applications. Ability to identify non-standard forms and determine action required. Must have good organizational skills and be detail- oriented. Ability to prioritize workload. Must demonstrate ability to perform multiple tasks simultaneously and maintain high productivity and accuracy. Requires good written and communication skills. Must maintain confidentiality with regard to patient information.

Driver Courier

The Driver Courier shall, at a minimum, have a high school diploma and a valid driver’s license from the state of legal residence and at least two (2) years good driving record. In addition, the Courier must be able to lift forty (40) lbs. Drives automobile or light truck to deliver messages, documents, packages and mail to various business concerns or governmental agencies. May transport office personnel and visitors, and perform miscellaneous errands, such as carrying mail to and from the post office and sorting or opening incoming and outgoing mail. May obtain receipts for articles delivered and keep a log of items received and delivered. May deliver items to offices and departments within an establishment.

Electronic Document Technician

The Electronic Document Technician shall have a high school diploma, but a Bachelor’s degree with coursework in Health Science or Information Science is preferred. The Electronic Document Technician will have five (5) years of related experience and two (2) years of direct experience with the management and processing of both electronic and paper files. This individual will have excellent communication, computer, and customer service skills. They will also be familiar with FDA terminology.

Senior Electronic Document Technician

The Senior Electronic Document Technician shall have a Bachelor’s degree in Computer Science or Information Management and four (4) years of experience in the Computer Science or Information Management field. The Senior Electronic Document Technician will be responsible for the management and oversight of the Electronic Document Room (EDR) operation. The Senior Electronic Document Technician will have excellent leadership, supervisory, training, communication, and records management skills. In addition, the Senior Electronic Document Technician will be detail-oriented and have the skills to maintain databases, electronic files, documentation, and computer tapes.

Program (Contract) Manager

The Program (Contract) Manager shall have a Bachelor's or Master’s degree in a technical, business, information/records management discipline and/or have a minimum of ten (10) years of project management experience, preferably in a Federal environment. This will include directing, managing, and coordinating resources and staff across multiple task orders/projects and locations. The Program Manager will have demonstrated knowledge of contracts analysis, contract compliance, document processing, database management, and records management. The Program Manager will have the ability to effectively communicate with the FDA CORs and ensure timely response for all communications and deliverables across all DOs/TOs. Professional certification is preferred.

Program System Analyst

The Program Systems Analyst shall have the requisite experience and familiarity to perform database requests when requested. The System Analyst must have knowledge to maintain database if malfunction or crashes in order to support the QASs during their period of performance. The Program System Analyst will provide services when needed on the current database whether requested by FDA or the Quality Assurance Specialist (QAS) staff.

Project Manager

The Project Manager shall have a Bachelor’s degree (preferred but not required) in a business administration, public administration, or a field closely related to records management and/or experience demonstrating abilities in the management of similar records projects for a minimum of eight (8) years, preferably in a contract environment. Education/experience can be combined to satisfy the requirement. This individual’s past experience must contain a significant amount of client customer service. The Project Manager will have demonstrated the ability to manage a regulatory document and records management effort including a staff of specialty and line managers. The project manager will possess knowledge of contemporary project management tools and will have a command of the core principles of effective management, including effective delegation, ownership, responsibility development and tracking. The project manager will have demonstrated ability to plan, integrate, and manage life cycle regulatory document operations involving document processing in high volume automated and manual operations and scientific data abstraction operations. The project manager will have the ability to effectively communicate with the COR, TO/DO PM, FDA management, user organizations, and technical staff. The individual must have an extensive knowledge of life-cycle Records Management processes including experience developing and implementing file plans, records inventories and records disposition schedules.

Quality Assurance Analyst (QAA)

The Quality Assurance Analyst shall have a four-year college degree (preferred but not required), preferably in health or science related field. Education/experience can be combined to satisfy the requirement. Responsible for verifying that each functional component of the project follows a defined process, which is in conformance with contractual requirements. Reports findings to project staff, line management of the organization, and the customer, as appropriate. Provides an independent assessment of how the project's development process is being implemented relative to the defined process and recommends methods to optimize the organization's process.

Quality Assurance Specialist (QAS)

The Quality Assurance Specialist shall have a four-year college degree (preferred but not required), preferably in health or science related field. They shall possess excellent computer skills and experience with the querying and use of databases. Education/experience can be combined to satisfy the requirement. The QASs shall also function as the vocabulary specialist, having knowledge of and experience with medical devices and device terminology in a commercial environment or in a health information processing environment. The QAS will perform Quality and Control of the data entry and correctness, document control & processing, and the overall quality of the performance of the scope of work. They shall respond to email and voice mail messages and assist stakeholders with complying with registration and listing requirements. The QAS’s shall also respond to policy questions.

Records Management Specialist I

The Records Management Specialist I shall have a minimum of a high school diploma and at least one (1) year of office, records, or computer experience. This individual must be able to work in both a paper and electronic production environment. They must also be able to lift thirty-five (35) lbs., bend and stretch to reach files, and push a fully loaded mail cart. Records Management Technicians will perform duties such as data entry, barcoding, filing, scanning, mail handling, customer service, and document processing.

Shredding Specialist

The Shredding Specialist shall have a high school diploma or equivalent.

Subject Matter Expert

The Subject Matter Expert shall have a Bachelor’s degree (preferred but not required) and at least three (3) years’ experience in a bioscience or records management related field. Education/experience can be combined to satisfy the requirement. Depending on project position, the person (1) must have the ability to abstract data from biologic applications into an Oracle or Access database and verify data and data entry or (2) must have the ability to develop and implant new file plans for records management. This individual will have the ability to effectively communicate with FDA user organizations and technical staff and be able to serve as the project alternate to the Project Manager.

Supervisor

The Supervisor shall have a minimum of a Bachelor’s degree and/or a minimum of four (4) years of progressively more responsible managerial experience in an information and records management environment. The individual assigned to this position will possess knowledge of contemporary project management tools and will have a command of the core principles of effective management. The individual assigned to this position will develop and maintain SOPs and plan and schedule production and resources to ensure turnaround requirements in these areas are met. This individual will have the ability to effectively communicate with FDA user organizations and technical staff and be able to serve as the project alternate to the Project Manager. The individual should have a general knowledge of life-cycle records management including the use of file plans, records inventories, and records retention schedules. In addition, they should be able to manage the employees and workloads for document room activities including, but not limited to, scanning, document processing, data entry, and paper and electronic file management.

Technical Information Specialist

The Technical Information Specialist shall have a high school diploma. A Bachelor’s degree with science or information management coursework is desirable. At least three (3) years of experience in an office environment with a records management background is preferred. The individual should have experience with reading and classifying scientific regulatory documents. In addition, they should have excellent oral and written communication skills, excellent customer service skills, working knowledge with the standard Microsoft suite of products, and experience in working areas such as document tracking databases, scanning, and micrographics. Excellent data entry skills and attention to detail is mandatory.

Senior Technical Information Specialist/Senior Task Leader

The Senior Technical Information Specialist/Senior Task Leader shall have a college degree (preferred but not required) in science or information management. Education/experience can be combined to satisfy the requirement. This individual will be proficient in reading, analyzing, classifying, and interpreting regulatory submissions. The ability to lead special project teams is preferred, with a minimum of three (3) years of experience specifically in records management. This individual will also be able to implement SOPs and train staff in their use. They should have experience with scientific regulatory documents, and excellent speaking, writing, and excellent customer service skills. In addition, the Senior Technical Information Specialist must have an in-depth background with computer use, including a working knowledge of the standard Microsoft suite of products. They should also have experience in areas such as quality control, overseeing document tracking databases, inventorying records, scanning, and micrographics.

DELIVERABLES

Specific deliverables and a schedule of deliverables will be identified in each DO/TO.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped in accordance with the requirements and specifications contained herein this contract. At a minimum, all deliverables shall be marked with the Contract Number and Contractor Name.