The Department of Health and Human Services (HHS), Food and Drug Administration (FDA) has a continuing requirement for Fully Integrated Records Facility (Offsite Document Control Center).

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 Contractor-Hosted Fully Integrated Records Facility Indefinite Delivery / Indefinite Quantity (ID/IQ) contract that will be available for use agency wide within FDA. This contract shall allow for Firm Fixed Price (FFP), Time and Material (T&M), Labor Hour (LH) type orders, or a combination thereof.

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.

• 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