FDA Data Management Program

THE DUE DATE FOR PROPOSALS IS MAY 27, 2010 BY 1PM EASTERN TIME THE SOLICITATION HAS BEEN UPLOADED TO THIS ANNOUNCEMENT 4/27/2010. THIS IS NOT A DRAFT. Questions related to the final solicitation shall be sent electronically to keith.austin@fda.hhs.gov no later then May 10, 2010 by 10 a.m. eastern time. Solicitation Number: 10-223-SOL-00082 - Presolicitation Notice Type: Presolicitation Synopsis: The Food and Drug Administration (FDA) intends to solicit proposals under solicitation number 10-223-SOL-00082 (subject to change) for a program called the FDA - Data Management Program (DMP). The NAICS Code is 518210 with a small business size standard of $25 million. Project Background: The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of all FDA regulated products such as human and veterinary drugs, biological products, medical devices, food and dietary supplements, cosmetics, and products that emit radiation. For each respective Center within FDA, legislation is set forth for voluntary and mandatory reporting of adverse events, product problems or complaints, and Good Manufacturing Practices (GMPs) as cited in the Federal Food, Drug and Cosmetic Act and the Public Health Service Act and other laws affecting the FDA. FDA receives these reports by electronic submission, mail, phone, fax, email, and via the internet. FDA requires support services for data entry and processing received reports. The key source of data entry includes Individual Case Safety Reports (ICSRs).1 These ICSRs are submitted to each Center in various formats. Currently, each Center has individual programs in place for supporting these legislative mandates and their respective missions. This contract shall provide the opportunity and means to align the individual Center programs with the Agency goal of a Unified Adverse Event Data Management Program, hereafter referred to as the Data Management Program (DMP). The FDA Center's missions and legislative authorization are presented below for FDA regulated products: The FDA Center for Drug Evaluation and Research (CDER) and the FDA Center for Biologic Evaluation and Research (CBER) perform a crucial part of FDA's mission, pre-market and post-market safety and efficacy assessments of human drugs and biological products. The collection and analysis of reports by FDA staff must occur throughout the entire life cycle of the product in order to identify occurrences associated with the use of a drug or biologic in humans that could not have been predicted by such methods as clinical trials and bio-statistical analysis. These occurrences of adverse events or product problems must be reported to FDA in order for the Agency to carry out its mission protecting the U.S. public health. CDER and CBER receive reports submitted by stakeholders such as manufacturers, importers, health care professionals, and consumers. In addition, FDA employees may obtain follow-up information and submit reports from the FDA field offices. For CDER and CBER the statutory provisions for FDA's requirement to record mandatory submission of adverse drug reports for an Investigational New Drug Application (IND) or New Drug Application (NDA), Abbreviated New Drug Application (ANDA,) Biologic Licensing Application (BLA)and OTC products in an adverse event reporting system is Section 505(k))(1)2 of the Federal Food, Drug and Cosmetic Act, 21 CFR 310.305, 312.32, 314.80 and 600.80, Public Health Service Act, and Public law 109-462 Medical Dictionary for Regulatory Activities (MedDRA), is a standardized international terminology for coding of medical information for regulatory communication. MedDRA was developed by the International Conference on Harmonisation (ICH); it is used in electronic transmission of Individual Case Safety Reports (ICSRs) following the ICH E2B standards. MedDRA enables medical accuracy and transparency in coding, and standardized communication of coded data between manufacturers/sponsors and regulators. The FDA Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices. CDRH has the responsibility for post-market surveillance such as monitoring the performance, safety, and effectiveness of marketed medical devices. The objective of post-market surveillance is to protect the public from actual or potential hazards associated with medical devices. CDRH receives device event reports submitted by stakeholders such as medical device manufacturers, importers, user facilities, health care professionals and consumers. Section 519 of the Federal Food Drug and Cosmetic Act authorized CDRH to record mandatory submission of reports to protect the public from actual or potential hazards associated with medical devices. The MDR Regulation (21 CFR Part 803) establishes the requirements for the mandatory reporting of adverse events involving medical devices. The Medical Device Amendments to the FD&C were enacted on May 28, 1976. The FD&C Act was amended again in 1997 by the Food and Drug Administration Modernization Act (FDAMA), which provide for streamlining the process of bringing safe and effective medical devices to the U.S. Market. Enactment of the Safe Medical Device Act of 1990 (SMDA) and the 1992 Medical Device Amendment made a significant impact upon the mandatory aspects of CDRH's post-market surveillance program. In accordance with the MDR regulation 21 CFR Part 803.32 and 803.40, these revisions created an obligation for user facilities to report deaths and importers to report deaths and serious injuries directly to FDA and to the manufacturer. The mission of the U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) is to protect the public health by ensuring that the nation's food supply is safe, sanitary, wholesome, and properly labeled, and that cosmetic products are safe and properly labeled. CFSAN-regulated products include dairy products, plant foods, beverages, seafood, dietary supplements, cosmetic products, infant formula, medical foods, and color additives to food. The CFSAN Adverse Event Reporting System (CAERS) is a post marketing surveillance system to collect, analyze, monitor, and report adverse events and product complaints for CFSAN regulated products. Both mandatory and voluntary reporting of adverse events and product complaints are processed through CAERS. In addition, specific legislation may require Centers to maintain stand-alone tracking systems such as infant formula and bioterrorism. Mandatory reporting for dietary supplements is authorized under the Federal Food, Drug and Cosmetic (FFD&C) Act Section 761 and mandatory reporting for reportable food is authorized under FFD&C Section 417. The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula (Section 417 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f)). Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the FD&C Act (21 U.S.C. 350d) are required to report to FDA when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Federal, state, and local Government officials may also use the RFR portal to report information that may come to them about reportable foods. The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. Post-marketing surveillance affords the primary means by which CVM obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product and manufacturing problems. CVM receives reports submitted by stakeholders such as: manufacturers, importers, health care professionals, and consumers. This contract, at the present time, will only address post-marketing safety reporting. The scope may broaden to include premarketing in the future. Section 512(l) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(l), and - 514.80(b) of FDA regulations (21 CFR 514.80) requires applicants of approved animal drugs to report adverse drug experiences and product and manufacturing defects. Product and manufacturing defects must be reported if they meet the criteria in 21 CFR 514.80(b)(1). Adverse drug events and product and manufacturing defects involving animals must be submitted based on the criteria in 21 CFR 514.80 (b)(2)(i) and (ii), and (4)(iv). Voluntary reports are also accepted from consumers and veterinarians. The Tobacco Control Act enacted by Congress and signed by the President in June 2009 created the Center for Tobacco Products (CTP). As the mission of this Center is developed, reporting regulations will be defined and may require collection of adverse event reports related to products that the Center regulates. This Center will be eligible to have a task order under this Agency-wide contract. Over time, FDA intends to replace multiple current legacy processes and data systems that are used for the receipt, processing, validation, and assessment of received reports. These transitions may require the adoption of new software, revised SOPs, and additional staff training under this contract. Additionally, FDA intends to adopt emerging data exchange standards which may impact future electronic submission procedures. FDA is in the early stages of transitioning to a single electronic internet portal for adverse event and product problem reporting for all products. This portal will be known as the Safety Reporting Portal. The Safety Reporting Portal will allow reports to be typed into a "rational questionnaire" internet application that tailors questions based on the type of report, product, event, etc. As FDA transitions to new technologies, it is expected that tasks under this contract will be impacted. These impacts will need to be assessed as they occur and modifications to task orders under this contract may need to be considered. Objectives: The objectives of the Data Management Program (DMP) are to obtain the services of a single Contractor to provide qualified support for: 1. Processing reports commonly known as Individual Case Safety Reports (ICSRs) such as triaging, registering (logging), tracking, imaging or scanning, data entry, data entry quality control, updating of data records (to include resolving duplicates and conflicting information), reviewing, editing, coding, coding quality control (QC), coding quality assurance (QA), filing and redacting, distributing, archiving, and shredding of physical media. Specific controlled vocabularies are utilized by each Center to standardize key data elements. 2. Processing incoming supplemental ICSR information from follow-up requests as outlined in item number one to include updating and linking to the existing database records. 3. Managing the receipt of ICSRs through various means such as fax, phone, mail, e-mail, compact disk, electronic gateway records, and other electronic systems such as Office of Regulatory Affairs Field Accomplishments and Compliance Tracking System (FACTS) and Emergency Operations Network (EON) which will require extraction, verification and coding of incoming data. 4. Route ICSRs sent to the FDA to the appropriate Center or Federal Agency. 5. Re-route ICSRs sent to the FDA in error to the appropriate Center or Federal Agency. 6. Processing incomplete ICSRs as required by each Center. 7. Sending FDA generated letters as required by each Center. 8. Tracking, routing and processing paper periodic summary reports (PSUR or PADR) as required by each Center. 9. Processing requests for information such as FOIA requests as required by each Center. 10. Providing statistical reports of work accomplished including performance reports and ICSR statistics in various formats as required by each Center. 11. Organizing, planning, and attending progress meetings between the Contractor's Project Manager and the FDA COTR (or his/her designees). 12. Maintaining operational logs, manuals, and checklists as required by each Center. 13. Developing and/or maintaining Standard Operating Procedures and monitoring Business Rules as required by each Center. 14. Providing a Management Plan to include the implementation of Communication, Quality Control, Training, and Contingency plans. 15. Performing User Acceptance Testing (UAT) of DMP system upgrades and providing feedback prior to the release of software into the production environment. 16. Providing a technical lead that will liaison with designated FDA IT support staff regarding performance issues. 17. Responding to changes in the processing of ICSRs as the Agency transitions to a new web-based data entry system, Safety Reporting Portal, and the Rational Questionnaire and implementation of the Food and Drug Adverse Event Reporting System (FAERS) or other upgraded or new software systems. 18. An initial start-up time period shall be required to establish all standard operating procedures, train personnel for data entry services, and have any required tracking systems developed in order to be fully operational as determined by each Center. Additional Information: THIS IS NOT A REQUEST FOR PROPOSAL. It is anticipated that one contract will be awarded with a base period from July 1, 2010 - June 30, 2011 with four (4) one (1) year options. This requirement is an 8(a) competitive requirement. The FINAL RFP solicitation may be an upload to this presolicitation notice. NO PHONE CALLS WILL BE ENTERTAINED. Please send questions or comments in writing to keith.austin@fda.hhs.gov. It is up to interested parties to check this site for the release of the solicitation as it will be available on the Federal Business Opportunities (FedBizOpps) website. The anticipated release date of the solicitation will be on or around April 26, 2010. Please watch this synopsis for updated information (if any) to the release date. The anticipated award date for this effort is June 30, 2010.