Revised_Attachment_1_-_IDIQ_Statement_of_Work.pdf
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- Fully Integrated Records Facility (Offsite Document Control Center) Federal contract opportunity
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- FDA-Off-Site-RIM-000141
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Revised Attachment 1 - IDIQ Statement of Work
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ATTACHMENT 1
ID/IQ STATEMENT OF WORK
CONTRACTOR-HOSTED FULLY INTEGRATED RECORDS FACILITY (FIRF)
1. 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.
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 the 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 following FDA Offices and Centers are stakeholders under this ID/IQ 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 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
(FSMA).
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. 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.
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.
2.1. FDA DIRECT DATA CABLE
Upon award of the Pre-Market Task Order (first task order issued under the ID/IQ), the Government shall 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 shall be in floor ducts, walls, columns, or below access flooring. The Contractor shall provide outlets, which shall 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 of other acceptable cable trays to prevent Government provided cable coming into contact with suspended ceilings or sprinkler piping. Cable trays shall 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.
2.1.1. 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 offsite document control services. It is expected that Contractors will be responsible for complete management of FIRF in which services are provided.
The FIRF shall comply with Federal Information Security Management Act (FISMA) and supplemental policies for securing document and records material and information.
The Offeror’s facility must be in accordance with the ID/IQ SOW and Appendices 1: FDA IT Facilities Requirements; 2: FDA Physical Security Requirements/Specifications for FDA Facilities and Addendum; 6A: Small Computer Room or LAN Closets Electrical Requirements version dated 10-5-2012; 6B: Large Computer Room General Specifications with Electrical Requirements Version 10-20-2010; 6C: Basic RP LAN room layout; 6D: Electrical BTU Loading Worksheet; and 6E:
Ground Bus. Note Appendices 6A through 6E, these are dependent on the type of Contractor’s facility’s footprint. Various sections apply in these documents to the different type of room(s) proposed.
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm
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.
2.2 DOCUMENT/RECORDS MANAGEMENT TECHNICAL ENVIRONMENT
FDA’s Document Control Centers (DCC) and Document Control Facilities (DCFs) ensure timely receipt, processing, temporary storage, 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. There are twenty one DCFs that provide records processing and support for the FDA.
By consolidating task areas into a centralized location, FDA is provided the opportunity for further cost savings and is better able to strategically respond to Agency space constraints through the consolidation of like functions performed by contractors supporting the individual product centers.
This type of work environment provides FDA with increased flexibility regarding managing space constraints to achieve cost savings.
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 4: Summary of Volume Submissions by Center; Appendix 5: FDA Document Control Facilities; and Appendix 6: CDRH Work Functions.
The FDA receives materials in multiple forms of media, which includes, but is not limited to, paper and electronic. 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.
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.
2.3 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.
Cosmetic, pharmaceutical, food, and medical device 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.
3 PURPOSE
The purpose of this ID/IQ 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, and cataloguing and then storage of documents and materials.
4 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 moving to a 100% electronic environment for new submissions;
• Implementing and promoting operational efficiencies;
• Implementing and promoting cost efficiencies; and,
• Transitioning document control and records services currently on-site to FIRF.
5 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, Photocopy, and Conversion 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
5.1 TASK AREA 1: PROGRAM AND TASK ORDER MANAGEMENT SUPPORT
The Contractor/Program (Contract) Manager 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 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:
• Base contract administration;
• Throughout the period of performance, develop, maintain, modify, and update plans to include: TO communication plan, quality assurance plan, quality control plan, training plan, transition plan, contingency plan, staffing plan, and Standard Operating Procedures
(SOP);
• For each TO, prepare a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls throughout TO execution.
• Program Management Plan;
• 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;
• Safeguarding 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.
5.2 TASK AREA 2: DOCUMENT PROCESSING, HANDLING, CORRESPONDENCE,
AND DELIVERY
Documents and records material shall be received at FIRF. 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 FIRF will be required to staff the mail room, sort mail, prioritize, triage, scan, bar-code/track, and distribute both U.S. mail and regulatory submissions to the FDA community or coordinate with U.S. mail couriers. 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 electronic copies (eCopies) of submissions provided to FDA on an electronic media (e.g., CD) into the official repository.
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 FOIA requests.
In addition, but not limited to, the Contractor shall perform the following 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 have the capability to provide expedited delivery services of FDA materials.
Expedited delivery is within one (1) to two (2) hours of an order being placed. The Contractor must possess the capability to deliver records materials after hours. After hours are after normal business hours Monday through Friday, weekends, and holidays. 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. 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. Distribution locations can be modified or changed throughout the review process for various reasons; thus requiring data entry changes in the applicable tracking system.
5.3 TASK AREA 3: DOCUMENT SCANNING, PHOTOCOPYING, AND CONVERSION
SERVICES
The Contractor shall furnish the necessary personnel, materials, services, and facility to do all things necessary for or incident to the performance of the work required for off-site scanning. 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 and track drop-off and pick-up;
• Prepare physical documents/files for imaging Image document/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;
• Load images to a FDA electronic records repository or copied to other media; and,
• Complete various quality control checks throughout the imaging process ensuring consistent image capture, indexing and repository upload/media transfer.
5.4 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 Contractor 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; and,
• Upload electronic data into Center repositories.
5.5 TASK AREA 5: TRACKING AND TEMPORARY STORAGE OF GOVERNMENT
RECORDS
The Contractor shall be responsible for notifying the FDA PM COR, 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.
Contractor representative tasks shall include:
• Adhere to retention and disposition schedules a part of identifying files to be moved to off-site locations for cataloguing and temporary storage and/or disposition;
• 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, donation, and accession of records to another FDA approved facility;
• Provide certificates of destruction at the request of TO CORs;
• On a real-time basis, update the inventory of documents and records accordingly;
• Transfer closed files to the Federal Records Center or a NARA approved commercial storage facilities.
5.6 TASK AREA 6: TRANSITION WORK ACTIVITIES
Transition activities take place to efficiently have the task order requirements transition from the incumbent Contractor to the new ID/IQ Contractor. As tasked, the Contractor may be required to develop transition-in and out plans for ITOs issued against this ID/IQ contract vehicle based on individual requirements.
5.6.1 TRANSITION-IN
A smooth and orderly transition-in among the Contractor or FDA and a predecessor or successor Contractor is necessary to ensure minimum disruption to vital FDA business. Transition-In Plans shall include at a minimum 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.
5.6.2 TRANSITION-OUT
A smooth and orderly transition-out between the predecessor Contractor, FDA, and 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 that a new successor Contractor is chosen. This will include at a minimum the following:
• Transition-Out Plan and Schedule;
• Schedule of knowledge walkthrough sessions;
• Provide “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;
• Submission of knowledge transfer documentation to include current and up-to-date Standard Operating Procedures;
• 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 vehicle. As tasked the Contractor staff shall be tasked to assist with the preparation and movement of documents between current facilities and new or existing sites. This will 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 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.
6.0 REQUIREMENTS
INFRASTRUCTURE AND EQUIPMENT REQUIREMENTS
• All infrastructures 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.
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 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.
• All FIRF 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. Security and Privacy Controls for Federal Information Systems and Organizations NIST SP 800-53, Rev. 4 (including updates as of 1/15/14).
(refer to: http://www.nist.gov/manuscript-publication-search.cfm?pub_id=915447)
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.
7.0 PHYSICAL ACCESS CONTROLS
Entrance into the Contractor’s FIRF are to be through 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.
8.0 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 a FDA authorized secure channel such as Cisco AnyConnect. All Contractors 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 the Contractor 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 shall provide Contractor with all necessary specifications for the Contractor to provide proper connectivity.
List of Appendices
Appendix 1 FDA IT Facilities Requirements
Appendix 2 FDA Physical Security Requirements
Appendix 2.A Addendum to FDA Physical Security Requirements
Appendix 3 Summary of Volume of Submissions (revised 6/19/14)
Appendix 4 FDA Document Control Facilities - This excel spreadsheet contains a list of FDA document control facilities; records system supporting software by Center; and tracking systems and repositories being used by each Center.
Appendix 5 CDRH Work Functions - This excel spreadsheet contains square footage of each function; 2012 and 2013 application submissions and file maintenance data; 2012 and 2013 eCopy Loading data; and 2012 and 2013 registration and listing data.
Appendix 6A Small Computer Room or LAN Closets Electric Requirements
Appendix 6B Large Computer Room General Specifications with
Appendix 6C Basic RP LAN Room layout
Appendix 6D Electrical BTU Loading Worksheet
Appendix 6E Ground-Bus
Appendix 7 Glossary of Terms (revised 6/19/14)
| 1. 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, v... |
| 2. BACKGROUND |
| 2.2 DOCUMENT/RECORDS MANAGEMENT TECHNICAL ENVIRONMENT |
| 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 ... |
| 2.3 21ST CENTURY ELECTRONIC BASED RECORDS INFORMATION MANAGEMENT (RIM) ENVIRONMENT |
| The FDA strives towards a streamlined 21PstP 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... |
| 3 PURPOSE |
| The purpose of this ID/IQ 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, scannin... |
| 4 OBJECTIVES: |
| 5 TASKS AREAS |
| 5.1 TASK AREA 1: Program and Task Order Management Support |
| 6.0 Requirements |
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