Draft_IDIQ_SOW.doc

CONTRACTOR-HOSTED OFF-SITE RECORDS SUPPORT

IDIQ STATEMENT OF WORK

1.1 INTRODUCTIONtc "TITLE" \f C \l 1

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.

1.2

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 Contractor-hosted Off-Site Facilities. 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 following FDA Offices and Centers are stakeholders under this IDIQ Vehicle:

· Office of the Commissioner (OC)

· Office of Regulatory Affairs (ORA)

· Center for Biologics Evaluation and Research (CBER)

· Center for Devices and Radiological Health (CDRH)

· Center for Drug Evaluation and Research (CDER)

· Center for Food Safety and Nutrition (CFSAN)

· Center for Tobacco Products (CTP)

· Center for Veterinary Medicine (CVM)

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 Act I, II, and III (MDUFA), Clinical Laboratory Improvement Amendments (CLIA), Medical Device Amendments, Safe Medical Devices Act, Electronic Product Radiation Control Provisions of the Food Drug and Cosmetic 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 (FSMA).

1.3

PURPOSE

tc "OBJECTIVES" \f C \l 1The purpose of this IDIQ contract is to obtain Contractor services related to several document control and records related activities throughout FDA. Initiatives include off-site document control activities at Contractor-hosted facilities. This includes receiving, processing, inventorying, scanning, and disposing of documents and records materials.

1.4 scope

The FDA Off-Site regulatory document and records control and electronic submissions handling processes are divided into the following major task areas: Program and Task Order Management Support; Document Processing, Handling, Correspondence, and Delivery: Document Scanning; Document Data Entry Services, Data Analysis, Tracking Services, and Stakeholder Support; Official Archive of Government Records; and Transition Work Activities. Support encompasses documents and records lifecycle activities, quality control, facility management, collection maintenance, scanning services, training, data mining, data entry services, stakeholder support and documents and records management.

Representative activities include but are not limited to:

· Base contract administration;

· TO receipt and response;

· TO communication plan, quality assurance plan, quality control plan, training plan, transition plan, and contingency plan;

· TO staffing plan;

· Develop and maintain management plans throughout the period of performance, modifying and updating the plans as necessary;

· Prepare monthly progress and financial reports;

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

· Safeguarding information;

· Provide risk mitigation;

· Coordinating Help Desk Support issues

· Conduct and participate in progress meetings, facility meetings, training meetings. performance meetings, demonstration meetings, and post requirements meetings; and,

· Respond to ad hoc data calls.

The IDIQ COR may request monthly reports from all TOs to obtain overall contract status.

1.5

OBJECTIVES:

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

· Standardize records management processes;

· Promoting transparency and accountability by better documenting Agency actions and decisions;

· Gradually move to a 100% electronic environment for new submissions;

(1) Presidential Memorandum – Managing Government Records: This lays out a broad strategy to reform government record keeping, in part by using electronic record keeping to enhance efficiency, accountability, transparency, etc. The memorandum can be viewed via the following link:

http://www.whitehouse.gov/the-press-office/2011/11/28/presidential-memorandum-managing-government-records

(2) OMB/NARA Memorandum - Managing Government Records Directive: This provides the 12/31/2019 deadline for management of all permanent records in an electronic format . This memorandum can be viewed via the following link:

http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-18.pdf

· Implementing and promoting operational efficiencies;

· Implementing and promoting cost efficiencies; and,

· Transition document control and records services to Contractor-hosted off-site locations.

Specific goals and measures will be addressed in each Task Order released under the IDIQ.

1.6

DOCUMENT/RECORDS MANAGEMENT TECHNICAL ENVIRONMENT

FDA’s Document Control Centers (DCC) and Document Control Facilities (DCFs) ensure timely receipt, processing, and distribution of applications to the FDA reviewer community. Currently, there are no off-site contractor-hosted DCC’s or DCF’s. DCCs provide full life cycle records operations and support. DCF’s provide targeted support operations. There are twenty one DCFs that provide records processing and support for the FDA. It is expected that the number of facilities will fluctuate during the life of this IDIQ vehicle.

FDA’s DCCs and DCF’s processed over 600,000 paper and electronic application submissions in Fiscal Year (FY) 2012. Each application submission may have multiple record keeping transactions (e.g. amendments, document preparation, imaging, login, hold, log out, advisory letters, and warning letters). Therefore, the number of transactions will be substantially greater than the number of unique application submissions. See Appendix XX for a list of Document Control Facilities (DCFs) and Appendix A for a Summary of Workload Volume of CDRH Submissions.

The FDA receives materials in multiple forms of media which includes but is not limited to paper, electronic, and physical electronic. Record materials include documents, letters, memoranda, completed forms, statistical and narrative reports, 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.

3.6.1 Technical Environment

The FDA’s technical environment is characterized as a multi-zone architecture, with each zone separated by switches and firewalls to support application system security. The first, or outermost, zone -- the “Presentation Zone” -- supports logic for the applications. The third, or innermost, zone -- the “Data Zone” -- contains database servers used by the applications. Additional “Transport Zone” and “Management Zone” network segments support routing into FDA’s data centers as well as specialized network and management services such as Active Directory, Domain Name Services (DNS), Backup/Recover, and Monitoring.

Within this environment, the data entry, document loading, and scanning applications used by FDA’s DCCs and DCFs involve a combination of custom-developed applications and commercial-off-the-shelf software that resides behind FDA’s firewall. Because of the nature of interactions among FDA’s applications, databases, and document repositories, they can only be accessed via FDA’s internal network. Further, the DCC/DCF contractor shall be users, not maintainers, of these systems. Full system life cycle management support and services are performed separately by FDA’s information technology (IT) contractors. The DCC/DCF contractor, however, must comply with the technical requirements and adhere to the security constraints in order to set up any off-site operation that requires a physical or virtual connection to the FDA network.

3.6.2

REGULATORY SUBMISSION TYPES

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, premarket or postmarket. Premarket 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.

3.6.3

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 by December 31, 2019. Currently, FDA receives electronic submissions in a structured format for regulatory submissions. 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, accompanied by a copy of the signed cover letter and the complete original paper submission. An electronic copy is not an electronic submission.

1.7

CONSTRAINTS

3.7.1

INFRASTRUCTURE AND EQUIPMENT CONSTRAINTS

· The Contractor shall comply with the Federal Information Security Management Act (FISMA) 2002. Information technology systems that will be used to process, store, or transmit federal information in support of this contract shall be segmented from Contractor’s Corporate Network and adhere to the National Institute of Standards and Technology (NIST) Special Publication (SP) 800 Series and associated Federal Information Processing Standard Publications (FIPSPUB) standards that meet security control baselines supporting high impact data in accordance with FIPS 199. (NIST SP 800-53 identifies the required security controls)

· Systems permanently connected to the FDA Network Infrastructure (VPN or dedicated connection) will inherit many of the existing FDA security controls, and these systems must adhere to the internal FDA processes and procedures.

· The FDA Master Approved Technology (MAT) list contains a list of software applications and equipment approved by the Office of Information Management (OIM). The approved technologies are determined to be compatible with FDA’s Technical environment. The MAT list is posted on FDA’s intranet. The MAT list will be available to authorized Contractor employees after contract award. In addition, FDA posts a list on the intranet of technologies not approved by OIM.

· FDA has instituted the Information Technology Information Management (ITIM) approval process in order to track technologies across the Agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor may be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion. FDA Center IT Investment Review Boards may need to be included in a coordinated review process. All Contractor peripheral equipment connected to FDA computers or laptops must be on the MAT List. If Contractor equipment and software is not on the MAT List, it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

3.7.2

REGULATORY CONSTRAINTS

· 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. For further information see: FDA Security Authorization Toolkit. SP 800-37 Rev. 1: Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach.

· All Contractor-hosted facilities must meet all of the standards in 41CFR, FPMR 101, ASHRAE, OASHA, 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. SP 800-53 Rev. 3: Recommended Security Controls for Federal Information Systems and Organizations.

· Federal Information Security Management Act (FISMA)—The E-Government Act (Public Law 107) - recognized the importance of information security to the economic and national security interests of the United States. Title III of FISMA requires each Federal Agency to develop, document, and implement an Agency-wide program to provide information security for the information and information systems that support the operations and assets of the Agency, including those provided or managed by another Agency, Contractor, or other source. Federal Information Security Management Act (FISMA).

· 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: NIST: Computer Security Division - Computer Security Resource Center.

3.8. REQUIREMENTStc "BACKGROUND" \f C \l 1

3.8.1

PHYSICAL ACCESS

The Contractor shall control physical access into all document control facilities through all controlled entry point(s). Visitors are 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.

3.8.2

NETWORK ACCESS

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. All Contractors accessing FDA’s network from remote locations are subject to FISMA regulations. Note that the Contractor may not access the network via their personal computers. If a direct connection is required from the Contractor facility to the FDA network due to bandwidth or security reasons, the Government shall provide Contractor with all necessary specifications for the Contractor to provide proper connectivity.

3.8.3

FACILITY AND EQUIPMENT REQUIREMENTS

Except as provided in Section 4.6, Government Furnished Equipment (GFE), or as provided in specific ITOs, the Contractor shall provide the facilities, IT equipment, furniture, phones, vehicles, mail totes, hand trucks, telecommunications equipment, access control equipment and sufficient connectivity and bandwidth to meet the ITO requirements. The offeror will house, as appropriate, all necessary documents, records, equipment, supplies to meet the workload requirements of the ITOs. The FDA will not pay for space or other resources that are not required to meet the needs of the issued specific task orders issued. Appendix A presents the initial set of off-site workload requirements for CDRH.

· The Contractor shall have the necessary infrastructures and equipment in place or possess the capability to efficiently set up infrastructures to support FDA’s off-site documents and records materials processing initiatives.

· The Contractor’s off-site facility must be able to be connected to the FDA network with acceptable speeds to support requirements identified in individual task orders.

· The Contractor must use secure transmission channels for the transfer of FDA data that are approved by FDA’s Chief Information Security Officer (CISO) and security team. Examples of potential secure transmission channels are, but not limited to, secure file transfer protocol (FTP), encrypted hard drives, firewall-to-firewall Virtual Private Networks (VPNs), FDA’s web portal submissions, authorized FDA internal cloud networks, and FedRAMP cloud providers.

· The facilities, systems, and equipment operated in support of this contract must undergo a security assessment and achieve a security Authorization to Operate (ATO) by the FDA’s Authorizing Official (AO) prior to processing, storing, or transmitting federal information. The Contractor shall cooperate and provide FDA access to, and information, regarding the contractor’s systems and equipment in conjunction with FDA’s efforts to ensure compliance with all federal and departmental security requirements. FDA access may include independent validation testing of controls and FISMA data reviews.

· Upon receipt of security clearance, as indicated in specific ITOs, the FDA will provide personal computers, tokens (fobs), and any essential accessories along with FDA network access to contractor staff.

· All Contractor peripheral equipment connected to the FDA network must be on FDA’s Master Approved Technology (MAT) list. The MAT list will be available to authorized Contractor employees after contract award. If Contractor equipment and/or software is not on the MAT List and connects to FDA’s network, it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

· For any contractor-provided equipment that uses FDA data, the Contractor shall maintain an accurate inventory with barcoding of all devices used in the performance of the contract.

· All documents and records material application software, hardware, upgrades, releases, and new interfaces connecting to FDA’s network shall be compatible with FDA’s technical environment or be capable of being configured to be compatible.

· The following documents shall be submitted at least annually or upon significant change to the environment and the details contained in the documents must be of the actual environment as built:

· System Security Plan (SSP)

· FIPS-199

· Risk Assessment (RA)

· Privacy Impact Assessment (PIA), which is signed off by the FDA Director of Privacy

· E-Authentication Form

· Business Impact Analysis (BIA)

· Information System Contingency Plan (ISCP), to include the relevant parts specific to the system being developed/maintained.

· ISCP Annual Testing

The FDA will supply the contractor with templates of security artifacts, as appropriate.

The FDA may stipulate a required delivery and personal computer set-up location and process outside of the vendor-provided facilities for all vendor-provided equipment prior to use in support of this contract.

3.9. GENERAL TASKS APPLICABLE TO ALL IDIQ SERVICE CATEGORIES

3.9.1 Contract Level Program Management

The Contractor shall provide the program management services necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all TOs and activities throughout the contract’s period of performance. The Contractor shall provide both contract-level and TO-level project management to establish control, management, monitoring, and notification mechanisms and shall work with the Government’s CO’s and CORs and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met.

3.9.2 Escalation Procedures:

The Contractor PM shall escalate issues related to any impediment to progress towards any deliverables defined in the IDIQ or an ITO. The Contractor shall follow escalation procedures consistent with the line of command in FDA. The Contractor shall follow this order of escalation when reporting to FDA personnel:

1. TO CORs

2. IDIQ COR

3. CO

3.9.3

QUALITY CONTROL:

As tasked, the Contractor may be requested to develop Quality Control Plans for ITOs and/or provide guidance on proper quality assurance methods.TThe Contractor PM shall provide and/or oversee Quality Control activities as identified in ITO(s). Quality Control activities for Document and Records Material and Information includes but is not limited to meeting Service Level Agreements; ensuring proper handling and safeguarding of material; identifying and mitigating risks; resolving issues; and adhering to processes and procedures. As tasked, the Contractor may be requested to develop Quality Control Plans for ITOs and/or provide guidance on proper quality assurance methods.

3.10. SPECIFIC TASKS

3.10.1. TRANSITION ACTIVITIES

3.10.1.1

TRANSITION-IN

On-Site Transition-In – A smooth and orderly transition-in between the Contractor or FDA and a predecessor or successor Contractor is necessary to ensure minimum disruption to vital FDA business. The Contractor will deliver a Transition Plan to the FDA, which will outline all activities necessary for smooth transition of work requirements from the incumbent to the new contractor at on-site facilities. The transition period shall begin at date of contract award and shall conclude up to 90 days later. Upon completion of the transition-in period, the Contractor shall assume full operating accountability and responsibility for all tasks. Transition-In Plans shall work in conjunction with the Quality Control Plan and include at a minimum description of parallel operations, 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

Representative activities may include:

· Conduct and coordinate all on-boarding activities with the Government and obtain secure badging for contractor personnel

· Ensure that staff identified as key personnel are available to work with Subject Matter Experts (SME) from the Government immediately after Task Order awards

· Engage in regularly scheduled meetings

· Become familiar with documented requirements

· Understand CDRH technical environment

· Become familiar with current implementations and activities

· Review and assess the health and performance of the current DCC onsite environment and providing improvement recommendations Off-Site Transition-In –The Contractor shall be responsible for outlining all activities necessary for smooth transition of work requirements from FDA on-site DCC to new off-site facility after receipt of ATO. The Contractor shall be responsible for relocation of all required document and records materials from the on-site facility to the off-site facility. The date and time frames for this transition will be stipulated in ITOs.

Representative activities may include:

· Relocation of all physical items, infrastructure, supplies, etc.

· Relocation of dedicated GFE items to new facility (e.g. GFE PC’s)

3.10.1.2

TRANSITION-OUT

The Contractor shall ensure a smooth and orderly transition out to ensure minimum disruption to vital FDA business. The Contractor will be required to submit and execute a Transition-Out plan to ensure business continuity for the FDA. The Contractor shall be responsible for the transition of contracted activities and services to the Federal Government or to a follow-on contractor by the end of the contract period of performance.

Representative activities may include:

· Providing FDA all training materials;

· Providing FDA with a current inventory (reconciled with FDA) of all Government-owned assets used by the Contractor

· Providing FDA with current versions of all standard operating procedures, guidelines, performance reports, and other pertinent information needed to continue the services being performed by the Contractor;

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

The Contractor will be responsible for the completion of all transition out activities for Task Orders under this IDIQ as described in the FAR 52.237-3 “Continuity of Services” Clause. Transition-Out Plans will be requested prior to the exercise of the final Task Order option period.

3.10.2

OFF-SITE FACILITY MANAGEMENT

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 off-site document control services. It is expected that Contractors will be responsible for complete management of Contractor-hosted off-site document control facilities in which services are provided. All Contractor- hosted off-site DCFs shall comply with FISMA and supplemental policies for securing document and records material and information. All off-site document and records facilities will be subject to applicable county, local, state and federal inspections to support work identified in ITOs and mandated by law.

3.10.3

RELOCATION SERVICES

As identified in ITOs, the Contractor shall be responsible (and incur all costs) to relocate Document and Records Material to off-site facility(s).

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 vehicle. Contractor staff may be tasked to assist with the preparation and movement of documents between current facilities and new or existing sites. As tasked, the Contractor will need 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.

3.10.4

OFF-SITE DOCUMENT CONTROL PROCESSING

The majority of effort under this IDIQ Service Category involves processing of documents and records material and information at Contractor-hosted Off-Site Facilities. Contractor activities under this task area include mail receipt, inventory, distribution, disposition, and retirement of documents and records material and information received and / or stored at Contractor-hosted off-site facilities.

3.10.5

DOCUMENT RECEIPT, HANDLING, AND PROCESSING

Documents and Records Material shall be received at Contractor-hosted off-site DCFs. Off-Site document control Contractor staff will receive U.S. Mail and deliveries via commercial and private couriers. Specific mail room processes will be identified in ITOs. The Contractor operating mailrooms will be required to staff the mail room, sort mail, prioritize, triage, and distribute both U.S. mail and regulatory submissions to the FDA community or coordinate with U.S. mail couriers. As tasked, the Contractor shall process required and voluntary electronic copies (eCopies) of submissions provided to FDA on an electronic media (e.g., CD) into the official repository. 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 FOIA requests. See the SOW and ITO SOWs for additional information on the types of user support services required by this contract.

3.10.6

DATA ENTRY, DATA ANALYSIS, QUALITY CONTROL, AND TRACKING SERVICES

The Contractor shall process documents and records material and information by:

· Entering data into Center-specific repositories and tracking systems;

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

· Uploading scanned files into the appropriate FDA Electronic Document Room or Tracking System.

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

· 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 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 files;

· Compress files;

· Create backup copies;

· Conduct scanning activities; and,

· Upload electronic data into Center repositories.

See Appendix XX for a High Level Example of Process Workflow Charts for paper, electronic, and mixed submissions Please note that Workflow Processes vary from Center to Center and will be subject to requirements identified in ITOs.

3.10.7

DELIVERY, DISTRIBUTION, AND HANDLING

As tasked, the Contractor shall provide courier service to multiple FDA facilities each weekday. Contractor is responsible for providing back-up couriers/drivers services. The Contractor will 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 ITOs. Some centers provide courier vehicles for distribution routes and other Centers opt to use Contractor-provided vehicles. 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 FDA reviewer community, Contractor staff, administrative staff, and program managers as needed/or instructed. New incoming records material may also be distributed to the off-site scanning vendor (s). Distribution locations can be modified or changed throughout the review process for various reasons; thus requiring data entry changes in the applicable tracking system.

· Contractors shall have the capability to provide expedited delivery services of FDA materials. Expedited delivery is less than four (4) hours of an order being placed. Specific requirements will be specified in each ITO.

· Contractors must possess the capability to deliver records materials outside of normal business hours. Specific requirements will be specified in each ITO.

· The drivers are expected to be operating on time in all situations, except when the Federal Government is closed. The Office of Personnel Management (OPM) is the authority that shall specify the status of the Federal Government during adverse weather conditions. In the absence of any OPM announcement, the presumption is that Federal Agencies are open and operating under normal circumstances.

· Upon notification of early release from OPM, if adverse weather conditions develop after the Federal Government has opened for normal business, the COR shall notify the Contractor of Facility closings, and specify the time for a final document pickup. Upon notification of delayed arrival from OPM, the COR shall notify the Contractor and discuss impacts to the work schedule, as tasked.

3.10.8

COLLECTION MAINTENANCE

The Contractor shall be responsible for notifying the TO COR and Documents and 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 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. Adherence to retention and disposition schedules is a part of identifying files to be moved to off-site locations for storage and/or disposition. As tasked, the Contractor shall support off-site storage programs, including the Federal Records Centers, FRC System, and Agency approved commercial storage vendors.

The Contractor will be responsible for conducting scheduled inventories of documents and records located at Contractor-hosted Off-Site Facilities and to track the file movement (and status of files) between 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 Contractors collect and inventory data, the inventory of data is not limited to a manual log, barcode system, and/ or Radio Frequency Identification Device (RFID). Inventory data may be uploaded into Center- specific tracking systems and databases.

Contractors shall barcode and jacket files before storing documents and records material at Contractor-hosted off-site facilities. The Contractor shall provide a methodology for tracking files stored at Contractor-hosted off-site facilities. Electronic submissions shall be stored in appropriate Center-specific repositories. Contractors shall apply adequate security standards and procedures when handling records information.

As tasked and authorized by the FDA COR, the Contractor shall prepare materials for shredding and / or shred materials. The Contractor shall maintain a listing of all documents destroyed on behalf of the FDA according to the method (tracking system, database, etc.) indicated in the TO. Contractors shall provide certificates of destruction at TO CORs request.

As tasked, the Contractor shall 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. Closed files are transferred to the Federal Records Center or NARA approved commercial storage facilities.

3.10.9

SCANNING, PHOTOCOPYING, AND CONVERSION SERVICES

Off-Site DCFs shall have the capability to provide scanning services. 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 required for off-site scanning at DCFs. Scanning services range from digitizing legacy material to processing new physical documents and records material. The majority of scanned services will be paper to electronic images. The Contractor will also be tasked to convert material such as film, videos, microfiche, blowbacks, and physical artifacts into digitized images.

Requirements for off-site scanning, photocopying, and conversion services will vary from Center to Center and will be outlined in the ITO’s. Generally, the Contractor will;

· Coordinate drop-off and pick-up;

· Prepare physical documents/files for imaging;

· Image document/files using FDA supplied hardware and software;

· 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;

· Load images to an 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;

· Maintain scanning equipment according to manufacturer specifications and warranty requirements; and,

· Monitor imaging software license use for burn rate.

3.11. TASK ORDER MANAGEMENT

For the TOs released under this contract, the Contractor shall provide TO-level project management to effectively manage tasks, monitor TO performance, manage Contractor staff and provide subcontractor management; and establish notification mechanisms for acceptance by the government. For each TO, the Contractor shall prepare a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls, to include QAPs - as required in ITOs - to be employed to meet the cost, performance, and schedule requirements throughout TO execution.

To successfully conduct TO management, the Contractor TO manager shall:

· Comply with reporting requirements as stipulated in the ITO;.

· Follow escalation procedures for problems, issues, and recommendations as specified in ITO’s;

· Participate in FDA’s program/project reviews, management briefings, stakeholder presentations, and cross-agency information exchanges, in order to provide expert counsel to DCC staff and document lessons learned as directed by the TO COR; and,

· Ensure proper exit criteria are followed when Contractor employees leave projects. Please note that this may be subject to change based on ITO requirements.