Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005
|Cost of Living-Pay 3/||
|Food Defense -
|Budget Authority FTE||
|Total User Fees||$17,020,000||$24,834,000||$23,738,000||+$1,096,000|
|User Fee FTE||161||167||172||+5|
|1/Contains a Budget Authority rescission of 0.59 percent for a total of $635,000 for Other Activities.
2/In FY 2004, a total of 104 Human Resources FTE was transferred from the FDA to the Department as part of the Secretary's One HHS Initiative. The Other Activities program share of this transfer was 32 FTE.
3/Pay increases shown on separate line, and not reflected in individual initiative areas.
4/For the purposes of the FY 2005 budget, FDA has assumed ADUFA's appropriations have been enacted and is in its second year.
Historical Funding and FTE Levels
|Fiscal Year||Program Level||Budget Authority||User Fees||Program Level FTE|
|3/ Includes FDA's FY 2002 Appropriation and the Counterterrorism Supplemental.|
- Provide centralized program direction and management services for Agency programs to ensure FDA's public health hazard prevention efforts are effectively managed within its regulatory framework;
- Provide management expertise and direction to support standards development for regulated products to effectively serve consumers and our industry stakeholders;
- Develop Agency-wide policy in legislation, consumer communications, public information, scientific coordination and regulatory requirements; and,
- Provide direction in the management of resources to support our science-based work. This includes financial, human and information systems resources, knowledge management and other critical infrastructure needs. Other more specific programs include: Freedom of Information Act activities and the administration of internal management controls consistent with the Federal Managers' Financial Integrity Act.
FDA's Other Activities program provides central program direction and administrative services for Agency programs to ensure that FDA's consumer protection efforts are effectively managed and that available resources are put to the most efficient use. This is accomplished through: Agency-wide policy development in medical affairs, scientific coordination, regulatory requirements, legislation, planning and evaluation, consumer communications and public information; management expertise and coordination in financial management, personnel, equal opportunity and Agency-wide diversity program functions, contracts and grants administration, procurement, property and space control, and communications systems.
Office of the Commissioner (OC): The Office of the Commissioner provides leadership and expertise to manage the Agency, serving as the focal point in coordinating crosscutting Departmental initiatives, and interacting with other Federal and state agencies, consumer groups, and industry. OC administers international program issues that include the coordination of the international conference on harmonization and World Health Organization functions.
The Office of Crisis Management (OCM) serves as FDA's focal point for coordinating emergency and crisis response activities, counter terrorism activities, interagency and intra-agency coordination of emergency and crisis planning and management, internal and external security, and other related activities on both a domestic and international level.
Office of Policy, and Planning (OPPL): The Office of Policy, Planning, and Legislation provides advice and assistance in policy development and oversees Agency rulemaking. OPPL ensures that internal and external stakeholders clearly understand FDA's challenges, achievements, and future directions.
Office of External Affairs (OER): The role of OER is to advise the Commissioner, Deputy Commissioners, Associate Commissioners, and other officials on Agency-level activities and issues that affect Agency-wide programs, projects, and strategies.
Office of Science and Health Coordination (OSHC): The Office of Science and Health Coordination's role is to advise and assist the Commissioner, Deputy Commissioner, and other key officials on scientific issues that have an impact on policy, direction, and long-range goals. The OSHC coordinates responsibilities for women's health issues.
Office of Management (OM): OM directs and oversees the agency-wide components of very different but related functions including managing FDA's budget, and is the focal point for the Agency's financial management, agency accounting policy and reporting. Annual Financial statements are prepared and audited as required by the Chief Financial Officers Act and OMB, GAO, and DHHS Accounting rules and requisitions are interpreted and implemented. The Office of Management is made up of four divisions: the Division of Accounting, the Division of Financial Systems, the Division of Budget Execution and Control, and the Division of Budget Formulation and Presentation.
Other Activities Increases for FY 2005
By FDA Strategic Goal
|FDA Strategic Goal||FY 2005 Increase||What the Increase Buys||Related Performance Goal(s)|
|Strong FDA||Cost of Living-Pay --+ $1,292,000||
|Efficient Risk Management: The Most Public Health Bang for our Regulatory Buck||
Bovine Spongiform Encephalopathy --+ $300,000
+ $3,402,000 --
(PDUFA -- + $2,890,000)
(MQSA --+ $4,000)
(MDUFMA --+ $273,000)
(ADUFA --+ $235,000)
|Protecting America from Terrorism||Food Defense --CT -- + $3,000,000||
PROGRAM RESOURCE CHANGES
Cost of Living- Pay: + $1,292,000
FDA's request for pay cost increases is essential to accomplishing its mission. Without a specially trained national cadre of scientific staff, FDA's ability to adequately carry out the mission of protecting public health and providing consumer safety will be compromised. FDA must maintain staffing levels and scientific capabilities that meet the demands of an increasing workload and new challenges. Payroll costs, which account for over 60 percent of our total budget, significantly impact all FDA activities.
The total Agency request for pay increases is $14,352,000. The Other Activities portion of this increase is $1,292,000. Without this, FDA's ability to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use will be significantly reduced.
Food Defense - Counterterrorism: + $3,000,000 and + 5 FTE
FDA must uphold its responsibility for ensuring the safety of approximately 80 percent of the Nation's food supply. The possibility of food products being used as a vehicle for attack is particularly worrisome because such an event potentially affects everyone in the U.S. FDA must have the capability to assess and then reduce risks associated with unexpected and potentially widespread health and safety threats. Resources would allow the Office of Crisis Management to provide funding for the Emergency Operations Network Project. This funding will:
- Play a crucial role in strengthening FDA's capability to identify, prepare for, and respond to terrorist threats, hoaxes, and incidents for FDA-regulated products that may adversely affect public health;
- Provide a comprehensive system for managing emergencies and related incidents handled throughout the FDA, including its centers and field offices;
- Provide a web-based connection for all FDA offices (including headquarters, centers, and field offices) as well as provide information to other FDA partners, such as states, counties and other federal partners, through which accurate real-time information about various incidents can be shared and discussed; and,
- Manage both routine and large scale emergency events involving FDA regulated products. By tracking our routine incidents in the system, we will have a detailed record of ongoing and historical events that can be referenced by appropriate individuals and capture the details of the incident and our required response. When large scale events occur, the role of the system can broaden to enhance the effectiveness of the agency's response.
Bovine Spongiform Encephalopathy (BSE): + $300,000
Resources would allow the Office of Crisis Management to upgrade its Emergency Operations. The resources are needed to:
- Upgrade equipment in the Emergency Operations Center (EOC), including further integration of communications systems and purchasing additional software to better manage a potential BSE incident;
- Implement a management system to ensure collaboration and development of geographic information, including geocoding of all firms being inspected for BSE; and,
- Provide equipment to facilitate EOC operation during activation, twenty-four hours a day, and seven days a week.
Administrative Efficiencies: - $5,371,000 and - 46 FTE
To fully embrace the President's Management Agenda, FDA is delayering its organizational structure, performing competitive sourcing reviews, modernizing its financial management system, and consolidating its information technology infrastructure. The Other Activities portion of these management improvements consists of - $5,371,000 and - 46 FTE.
Prescription Drug User Fee Act III (PDUFA): + $2,890,000 and + 1 FTE
The PDUFA authorized the FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review. These additional resources were to be used to hire and support additional staff for the review of human drugs so that safe and effective drug products reach the public more quickly. The Bioterrorism Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products. These amendments are effective for five years and direct FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction with sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and develop principles for improving first-cycle reviews. The increases will contribute to meeting these mandated directives and performance goals that have been negotiated with industry.
Medical Device User Fee and Modernization Act (MDUFMA): + $273,000 and + 2 FTE
Sound, risk based review processes are imperative to ensure that medical devices on the market are safe and effective. To strengthen and expedite FDA's medical device review process, MDUFMA was authorized in FY 2002 as a multi-year effort. This legislation authorizes the collection of user fees for the review of medical device applications from those who submit premarket applications, certain supplements to those applications, and premarket notifications. The funds, which supplement annual appropriations for the medical device review program, will allow FDA to continue:
- Acquiring and training staff to meet a set of aggressive performance goals for expediting the review of medical device applications;
- Promoting public health with major improvements in review of expedited submissions for medical devices; and,
- Making major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.
Animal Drug User Fee Act (ADUFA): + $235,000 and + 2 FTE
Safe and effective animal drugs allow food animal producers to maintain healthy animals, and help ensure that resulting food products will be safe, wholesome, and free of drug residue, and that companion, service animals that assist the disabled, and other animals such as zoo animals will live healthier and longer lives.The ADUFA program, under which new animal drug applicants, sponsors, and manufacturers incur a fee to expedite their applications, will help provide a cost-efficient, high-quality performance-driven review process. Modeled after PDUFA, this fee has strong industry support and provides a complementary set of incentives to all stakeholders. The increase of $235,000 will cover inflationary costs and rent costs for additional staff associated with the implementation of ADUFA.
Mammography Quality Standards (MQSA): + $4,000
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women. Experts estimate that one in eight American women will contract breast cancer during their lifetime. The MQSA was signed into law in 1992 to address the public health need for safe and reliable mammography and requires that mammography facilities be certified by October 1994 to be able to remain in operation, and inspected annually to ensure compliance with national quality and safety standards. MQSA was not reauthorized by the 107th Congress because of concerns about the need to improve the skills of physicians reading mammograms and the need for interpretive skills assessment to be added to existing MQSA continuing medical education requirements. The FDA has been working with congressional staff to address these concerns and reauthorization of MQSA is expected in the current congressional session. The fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards. The increase of $4,000 will cover inflation.
PROGRAM ASSESSMENT RATING TOOL (PART)
In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological Health) and was rated as "results not demonstrated" due to a lack of long-term outcome goals. To address this concern, long-term outcome goals were developed.
For FY 2005, the Office of Management and Budget conducted a second program review that treated FDA as a single agency program. In this review, FDA received a rating of "moderately effective" and score of 77 percent, up from 59 in FY 2004. This was due to considerable improvements in developing long-term agency-wide outcome goals that will demonstrate its effectiveness and impact on the public health. FDA also reduced the number of performance goals, and made various management improvements that further streamline its infrastructure while supporting core, mission-critical public health activities.
The Other Activities program shares in an agency-wide outcome goal of reducing administrative overhead through the reduction of the number of administrative staff. All of the agency's outcome goals support the Department's priorities and Administration's initiatives with the intent to improve the health and well-being of the American public.
JUSTIFICATION OF BASE
EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK
Base resources will be used to conduct science-based risk management in all agency regulatory activities, so that the agency's limited resources can provide the most health promotion and protection at the least cost for the public.
Bovine Spongiform Encephalopathy (BSE) and Other Transmissible Spongiform Encephalopathies (TSE)
FDA works closely with the USDA, Customs and Border Protection, in the Department of Homeland Security (DHS) and state agricultural and veterinary agencies on the implementation of BSE regulations and controlling imported products. FDA supports the department-wide action plan outlining new steps to improve scientific understanding of BSE, commonly known as "mad cow disease," and other TSE diseases, (e.g., CWD).
- Assist in the development of legislative initiatives to update FDA's regulatory authority to encompass this new public health threat and develop regulations to prevent transmission of TSEs through FDA-regulated products;
- Monitor international epidemiological and other scientific findings regarding BSE/vCJD incidence to develop timely blood donor policy and take appropriate action for safeguarding FDA-regulated products;
- Catalogue and update databases of FDA regulated products which contain information about animal products used in manufacturing and regularly evaluate product risk;
- Leverage with state agencies by funding contract inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts; and,
- Train Federal and state inspectors on the BSE feed regulation; USDA's Animal Plant and Health Inspection Service authority and approach; and, what to look for and when to sample.
EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION
Resources will be used to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products. These activities include:
- Develop an FDA-wide consumer communication infrastructure and implement a consumer-media outreach strategy that is designed to help both consumers and patients understand how to live better, healthier lives;
- Create and leverage external collaborations with healthcare providers, and public and private healthcare organizations and institutions to increase both the reach and consistency of the FDA's "Better Informed Consumer" message; and,
- Seek out speaking opportunities for FDA to communicate directly with diverse consumer segments. This will be done in collaboration with the agency's Public Affairs Specialists as well as the Office of Special Health Issues, and the Office for Public Affairs.
Education and Outreach
FDA develops regulatory-based action plans across its different product centers in collaboration with other agencies in areas with great threat to public health, such as antimicrobial resistance and BSE, and ensures these actions are successfully implemented across the Agency.
IMPROVING PATIENT AND CONSUMER SAFETY
FDA has a unique opportunity to develop more direct access to databases that will allow us to rapidly assess risks and improve the safety of medical products. Important information about FDA-regulated products also needs to be made readily available to health care professionals to facilitate the safe use of medical products.
- FDA will develop and foster collaborative efforts with private and public health care systems to create interactive data systems for identification of medical product risks in real-time and will work with other agencies in HHS and standards development organizations to develop standards for communication of safety information; and,
- FDA will work with the National Library of Medicine to set up a new way to distribute up-to-date and comprehensive medication information in a computerized format for use in health care information systems;
The Best Pharmaceuticals for Children Act directs the Secretary of FDA's Health and Human Services to establish an Office of Pediatric Therapeutics within Office of the Commissioner to coordinate all FDA pediatric activities which will:
- Continue to assure the further development and issuance of written requests for pediatric studies, and the publication of the final study reports in the docket; review submitted results from these pediatric studies in a six month timeframe; and the disseminate appropriate information to the public;
- Enhance the surveillance of adverse events in children and coordinate with the NIH in developing "off-patent" drugs for use in children; and,
- Negotiate labeling concerns with listed drug holders and if necessary identify product labels requiring appeal activity and present to the Advisory Subcommittee.
FDA's Office of Combination Products (OCP) was established on December 24, 2002, as required by MDUFMA. The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic and device-biologic combination products. The Office of Combination Products will:
- Determine whether a product is a human drug, human biologic, human medical device, or a combination of any of these and, if determined to be a combination product, assigning an FDA Center with primary jurisdiction for review of a combination product;
- Serve as a focal point for combination products issues for internal and external stakeholders; and, ensure consistency and appropriateness of postmarket regulation of combination products and submit annual reports to Congress on the Office's activities and impact;
- Ensure timely and effective premarket review of combination products by overseeing reviews involving more than one agency center; and, resolve disputes regarding the timeliness of premarket review of combination products; and,
- Work with FDA Centers to develop guidance or regulations to clarify the agency regulation of combination products.
Human Subject Protection
FDA enhances the capacity and productivity of the Nation's health science research enterprise through strengthening the mechanisms for ensuring the protection of human subjects and the integrity of the research process.
- Improve the human subject protection system and the integrity of the research process through the development of regulations that would, for example:
- Establish a system to report fraud and scientific misconduct in clinical trials and build additional safeguards for children enrolled in clinical investigations;
- Establish a registration process for Institutional Review Boards (IRBs) to allow better education of, and communication with, IRBs and to facilitate FDA inspections of IRBs; and,
- Establish standards for the acceptance for the review of foreign clinical studies not conducted under an investigational new drug application that do not rely on now outdated versions of the World Medical Association's Declaration of Helsinki.
- Implement an improved quality assurance and quality improvement program for the agency's Good Clinical Practice (GCP) activities, FDA's GCP Bioresearch Monitoring Program and FDA's intramural and extramural research programs, that would provide for the systematic monitoring and evaluation of the various aspects of these programs and a process to allow program components to self-evaluate activities and identify those that can and should be improved; and,
- Develop and present education and training programs on good clinical practice and human subject protection to major Academic Medical Institutions.
PROTECTING AMERICA FROM TERRORISM
FDA has several major objectives that address these challenges:
- Facilitate the development and availability of medical countermeasures to limit the effects of a terrorist attack on the civilian or military populations and enhance our emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack;
- Ensure the safety and security of FDA personnel, physical assets, and sensitive information; and,
- Maintain FDA Emergency Operations Center (EOC) by doing the following:
- Track, and investigate incidents and emergencies, and investigate consumer complaints;
- Assist in the development of legislative initiatives relating to record keeping in the food industry as part of the Bioterrorism Bill;
- Coordinate FDA responses of HHS Nuclear/Radiological Terrorism Continuity of Operations. Participate in DHHS Radiological and Smallpox Exercises and draft the FDA Radiological, Biological and Chemical Response Plans; and,
- Develop guides for Produce Farm investigations and traceback procedure for eggs, and developed Response Plan for Cruise Ship outbreaks; and, initiate and coordinate traceback investigations.
More effective regulation through a stronger workforce will help FDA in recruit and retain a world-class professional workforce, and conduct effective and efficient operations to accomplish our mission, and meet the objectives of the President's Management Agenda. In support of these objectives, FDA will:
- Hire additional staff that will enhance our diversity in science and train current staff to keep skills current as medical device technology evolves;
- Support the President's Management Agenda and the agency's competitive sourcing effort by performing cost comparison studies for commercially identified functions to increase efficiency and effectiveness of Agency management;
- Improve Agency financial management systems and integrate performance and budget information to support resource decisions; and,
- Develop and implement a performance management system to effectively and efficiently link organization and individual accountability; and, provide employees with the tools needed to do the job.
Shared Services was implemented on October 1, 2003 to create a portfolio of services that are aligned with our customer's needs. These include transactional services, products and information, including specialized services to fit specific customer segments and contain multiple mechanisms to ensure employees are well served, can provide feedback, and have ease of access This service delivery model for internal administrative support functions has been successfully implemented in the private sector for more than 10 years and combines the best of centralized and decentralized organization structures.
The SSO is governed by a council which includes representatives of both providers and customers. Service level agreements formalize performance expectations such as costs and establish how business units support the process, is designed to help FDA focus on its core business, create satisfied customers and employees, leverage technology and information, and more effectively manage costs. In FY 2005, FDA expects to:
- Enhance the Employee Resource and Information Center to facilitate the delivery of services, as well as, track the timeliness of responses to service calls, etc. ERIC will continue to be key to the maintenance service levels as defined in written agreements with business units;
- Continue identifying processes for business process re-engineering; and,
- Begin development of a fee-for-service system for services provided by the SSO.
The Agency has also consolidated its IT systems by establishing an IT SSO with a formalized governance process to improve the review and approval of new IT initiatives, including potential E-government candidates.
Continue its support of FDA programs by the issuance of contracts and grants. The request will enable FDA to:
- Continue to convert contracts to performance-based service contracts to meet OMB goals and to solicit proposals under A-76 procedures to perform cost comparison studies; and, continue outreach efforts to identify small and disadvantaged businesses to perform Agency requirements;
- Support the consolidation efforts to unify procurement systems into one common management framework across the Department, identify common contracting requirements, and consolidate FDA's procurement activities into the FDA SSO; and,
- Complete move to use of the NIH IMPAC2 system as a fully operational electronic grants system with the ability to integrate with the Office of Financial Management, program staff, and Payment Division; and, complete work towards transitioning into the single Grants.gov portal that would allow recipients and grant-making agencies to electronically submit applications to FDA.
- Continue support for facilities improvements (Phase I and II of the White Oak Project have received appropriations for design and construction from Congress, and construction is in progress. Also, a shared use building at White Oak has been funded and is slated to begin construction in FY 2004 with completion in FY 2005).
FDA financial systems support all of the agency's financial activities and are mission critical needs for our public health mission. Improved financial performance includes initiatives to reduce erroneous payments, reengineer business processes to include accounting operations in field offices, and plan for a new core financial management system. These endeavors are vital to comply with changing Federal financial requirements, maintaining a clean audit opinion, and integrating accounting and financial systems throughout DHHS.
- Strengthen information system security program controls by completing security plans for all major financial application and upgrade current database system for legacy systems in order to strengthen access control;
- Ensure the integrity of major financial applications by reviewing and updating the financial management's software development and change control process to facilitate year-end closeout, financial statement preparation, and CFO audit activities;
- Implement the UFMS General Ledger, and complete, plan, and implement the second and third phase of the Accounts Receivable, Accounts Payable and Purchasing modules of Oracle Financial's. These phases will also include planning for the interfaces for procurement, property and travel;
- Implement a reporting system that allows the user to query and report on the financial system providing up-to-date information in order to make intelligent decisions on how to best spend FDA resources;
- Complete planning for the Activity Based Costing (ABC) system and UFMS integration;
- The Central Accounting System, FDA's primary financial management system, is certified by GAO and conforms to HHS standards for accounting systems, including use of uniform transaction codes, account structure, and standardized data fields. This core financial system interfaces with the HHS Central Payroll System, Payment Management System, FDA Procurement System, and the Treasury Departments GOALS System. This system will be decommissioned in FY 2005;
- Travel Manager is an off-the-shelf product for planning, authorizing, budgeting, monitoring, reimbursing, and reporting on employee and non-employee travel activities. It combines automated travel regulations, government forms generation and electronic document processing, into a powerful, easy-to-use software service. This system will be interfaced to the General Ledger in FY 2005; and,
- PRISM is the Agency-wide procurement system that will allow for electronic preparation and placement of contracts and purchase orders. The system streamlines and simplifies purchasing processes, speeds up processes due to parallel processing, reduces the amount of FTE spent creating and tracking procurement documentation. The integration between PRISM, PeopleSoft Asset Manager and the FDA General Ledger will result in increased data quality.
Support the 24 President's Management Agenda e-Gov initiatives and Departmental enterprise information technology strategic initiatives, and an enterprise approach to investing in key IT initiatives such as the Federal Health Architecture, the Secure One HHS program, and Public Key Infrastructure. These investments will enable HHS programs to carry-out their missions more securely and at a lower cost.
- Continue deployment of the Enterprise Architecture to additional business processes in order to continue implementation of data standards and system integration strategies to eliminate redundancy and increase effectiveness; and,
- Continue use of established IT investment review and decision making mechanisms, to include the Technical Review Board, the IT Capital Investment Review Board and the IT Portfolio Management tool, in order to facilitate the review of the progress of FDA IT initiatives and identification new opportunities.
- The Agency Information Management System (AIMS) provides integrated, automated support for administrative, management, and mission-specific processes. AIMS simplifies the current business processes by providing a single system;
- SCIENCE FIRST is a web-based knowledge management system that enhances FDA's science base by providing state-of-the-art information technology, IT, to optimize knowledge management of scientific resources among the different centers and to facilitate communication among the scientific community. One of its impacts is to bring together geographically dispersed scientific information sources ranging from simple seminar postings to complex FDA toxicology and carcinogenicity relational databases, to commercial CD-ROMs and Internet scientific sites;
- The Demographic Information and Data Repository projects, DIDR, is a set of projects proposed in response to Congress’ mandate to develop a database focused on women's health activities. The Agency-wide repository will hold information on product safety and efficacy, with clinical study data, review documents and labeling as the first elements targeted for inclusion. DIDR projects are directed at upgrading and modernizing the FDA's information management infrastructure related to health and regulatory information, to improve decision-making and risk management for sub-populations and improve the delivery of services to consumers and industry through the adoption of Agency-wide standards for data;
FDA Unified Registration and Listing System
Under the stringent time constraints mandated by the Bioterrorism Act of 2002, FDA fully implemented an on-line Food Facility Registration Module which is capable of handling 5,000 on-line registrations, (required from domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States), simultaneously via the Internet. In addition to responding to these requirements, FDA provided unified account management and single on-line entry point to be used for all of our Listing systems. As specified under the Bioterrorism Act, a paper process including a paper processing facility has been established to accept registrations via mail, fax, etc., to enter these into the electronic system, and to respond via paper to facilities doing business utilizing paper forms.
The following table and graphs show the increased use of the Internet as a tool by FDA's business community:
Providing Valuable Public Health through the Internet
In support of our Better Informed Consumer strategic goal, we utilize our web site to provide critical information of interest to health professionals, patients, consumers, industry, state and local officials, and many others, responding to their changing needs.
Prescription Drug User Fee Act (PDUFA)
The Bioterrorism Act of 2002 reauthorized PDUFA and the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products. Specifically, Congress directed FDA to expedite the drug development and drug process by complying the goals set forth in a June 4, 2002 letter from the Secretary. Major performance goals for FY 2004 include:
- Complete review and action on 90 percent of standard original NDAs/PLAs/BLAs within 10 months of receipt;
- Complete review and action on 90 percent of priority original NDA and PLA/BLA submissions filed within six months of receipt;
- Complete review and action on 90 percent of standard PDUFA efficacy supplements within 10 months; and complete review and action on 90 percent of priority PDUFA efficacy supplements within 6 months of receipt;
- Complete review and action on 90 percent of Class 1 resubmitted original PDUFA applications within 2 months; and review and act on 90 percent of Class 2 resubmitted original PDUFA applications within 6 months of receipt; and,
- Complete review and action on 90 percent of PDUFA manufacturing supplements within 6 months of receipt, and complete review and action on 90 percent of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.
In addition, FDA will be striving to meet other PDUFA goals, including the areas of meeting management, clinical hold responses, dispute resolution, protocol assessment/agreement, first cycle performance, continuous marketing application pilot programs, and performance management and electronic submission management initiatives.
Medical Device User Fee and Modernization Act (MDUFMA)
The Medical Device User Fee and Modernization Act of 2002 authorized the collection of user fees to enhance the medical device review process and established fees for medical device applications. MDUFMA is in effect for five years, from 2003 through 2007, with related performance expectations. Specifically, Congress directed FDA to expedite the medical device review process by meeting the goals set forth in a letter from the Secretary.
FDA will also strive to meet other MDUFMA goals, including providing guidance on bundling of multiple related submissions and modular PMA review. The agency will work to improve the scheduling and timeliness of preapproval inspections. And, beginning in FY 2004, the agency will hold annual public meetings to review and evaluate the implementation of the MDUFMA program in consultation with its stakeholders.
Mammography Quality Standards Act (MQSA)
The Mammography Quality Standards Act of 1992 requires that mammography facilities be certified and inspected annually to ensure compliance with national quality and safety standards. The fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards. The current MQSA legislation expired September 30, 2002 and is expected to be reauthorized.
SELECTED FY 2003 ACCOMPLISHMENTS
EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION
Education and Outreach
- Coordinated efforts of the FDA Task Force on Consumer Health Information for Better Nutrition to institute procedures for reviewing health claims made on food labels and fostering science-based labeling leading to better information to guide nutrition choices; and,
- Led the FDA Obesity Working Group efforts to develop a clear, coherent and effective message to unify various public and private efforts to reverse this epidemic.
IMPROVING PATIENT AND CONSUMER SAFETY
- As part of the FDA's counter-terrorism activities, funded four studies on prescription medications used to treat conditions that could occur after a terrorist attack in special populations: pregnant and lactating women and the elderly. These studies have received Institutional Review Board (IRB) approval and are recruiting subjects;
- FDA's Office of Women's Health (OWH) awarded contracts to seven academic institutions to conduct clinical research on women's health issues of regulatory interest. These institutions will conduct research studies in response to specific regulatory questions in women's health over the next five years;
- Launched the Menopause and Hormones Information Campaign on Capitol Hill, to help women understand the benefits and risks of this therapy, with information in English and Spanish, web sites and telephone numbers for further information and the most up-to-date hormone therapy information;
- Continued progress on the Demographic Information and Data Repository Development Program, to expand the foundation for development of an Agency-wide knowledge management for improving the collection and use of subpopulation data (sex, race, ethnicity and age) in clinical trials and labeling. Specifically, a draft guidance for the Collection of Race and Ethnicity Data in Clinical Trials was published, comments reviewed and the guidance updated which standardizes the reporting of race and ethnicity in clinical trials; and,
- Coordinated a Mammography Outreach Program designed for the African-American and Hispanic Community Leaders to use in their community to promote the message that early
- Funded the study "Self Monitoring of Blood Glucose with Finger Tip Sampling vs. Alternative Site Sampling; Source of Variability and Effect on Long Term Glycemic Control" to address the concern that diabetes control may be different when monitoring by finger stick versus an alternative site; and,
- At the request of our stakeholder organizations, continued dissemination of Take Time to Care about Diabetes (TTTC) materials and developed plans to conduct another major public awareness campaign to be held in February 2004. This campaign will make the connection between diabetes, obesity, and cardiovascular disease and will leverage resources from these new national partners that represent disability groups, health insurance companies, and the entertainment industry.
PROTECTING AMERICA FROM TERRORISM
Office of Crisis Management
FDA’s Office of Emergency Operations, the Office of Security Operations, and the Office of Counterterrorism were reorganized to create the Office of Crisis Management.
- Managed 198 significant emergencies and incidents during FY 2003, including 118 food emergencies (outbreaks, tampering reports, and adverse reactions), 16 drug emergencies, 3 incidents related to biologics, 10 veterinary product issues, 13 medical device problems and 38 other emergencies (natural disasters, terrorism related reports and emergency inter-agency training exercises). In addition, 33 tracebacks were initiated and coordinated by the Emergency Group;·
- Participated in TOPOFF 2, a full-scale, fully functional counterterrorism exercise, in May 2003. This exercise was intended to simulate two separate terrorist attacks: detonation of a "dirty bomb" in Seattle and aerosol release of pneumonic plague in Chicago. FDA activated its Emergency Operations Center (EOC), deployed representatives to the field, assessed the safety of potentially affected products, issued guidance and press, and FDA Centers and Offices collaborated to address issues related to availability and safety of medical countermeasures;
- Supported EOC for Hurricane Isabel with geographic information that provided mapping tools that identify potentially affected FDA regulated firms and offices in North Carolina, Virginia, West Virginia, Maryland and the District of Columbia;
- Worked to facilitate the nationwide assignment conducted in conjunction with Operation Liberty Shield which included domestic inspections of targeted food firms and sampling of targeted food commodities based on risk/threat assessments;
- Assisted the field staff in the development of a process and procedure for the collection of hazardous sample collections, including the creation of a team of "second responders," who may collect product samples associated with a terrorist or tampering event and appropriate training and equipment needs were identified and obtained for the two FDA teams undergoing training;
- Provided increased security measures for Select Agent Labs and additional security measures for all other FDA facilities to include additional locking devices, locking refrigerators and locking storage containers for select agents in FDA laboratories; x-ray machines, magnetometers, blast mitigation film, bollards, barriers, explosive detection devices, fencing, lighting, and other security measures deemed necessary to protect FDA facilities and personnel;
- Processed over 300 ANACI investigations for FDA employees working in Select Agent Labs and over 50 ANACI (Secret) investigations of various state employees to assist the field in their response efforts;
- Processed over 2,200 backgrounds/clearances for FDA employees, contractors and visiting scientists in FY03. This total includes an increase of our National Security Clearances (Secret/Top Secret) from 100 to over 500; and,
- Established a Task Force to develop Continuity of Operations Plan (COOP) plans and capabilities. Phase I includes the headquarters offices located in the Washington, DC metropolitan area. Phase II includes COOP development for the ORA Regional and District Offices and for NCTR.
- Continued liaison with the Rockville HR Center to provide efficient and effective personnel servicing in a consolidated environment. Provided strategic direction in Human Resource issues to the senior management of FDA and increased and expanded the use of hiring and educational programs for minority and disabled student interns, and established formal partnership agreements with Historically Black Colleges and Universities (HBCU) and Hispanic Serving Institutions (HSI), Tribal Colleges and Universities (TCU), and the Asian American and Pacific Islander Initiative (AAPI).
FDA's Competitive Sourcing Accomplishments are as follows:
- Successfully competed five percent of its commercial activities in FY 2002 and 10 percent in FY 2003 as shown in the following table.
|Name of Function/Organization||FTE||Results||Estimated Annual
|Phase I Studies|
|Scientific/Medical Library Services
|Graphics and Visual Information Services
|In House Win
(No Technically Acceptable Bids Received)
(No Technically Acceptable Bids Received)
|Web Publishing Services
|Phase II Studies|
|Facilities Real Property Management
|In-House Win (No Responsive Offers Received)||$304,000|
|Biological and Physical Science
Laboratory Technician Services
|In-House Win (No Responsive Offers Received)||$487,000|
|ORA General Accounting (Standard Competition)||
|In-House Win (Best Value)||$567,000|
- Won all Most Efficient Organization (MEO) competitions with a cost savings of approximately $3.27 million annually;
- Assisted the Departmental steering committee in planning for the proposed consolidation of 40 HR offices into 4, which began in FY 2004. The four offices will be located in Bethesda, Atlanta, Baltimore and Rockville. In preparation for this we have streamlined automated systems, all OPDIVs will be using the Enterprise Human Resources and Payroll (EHRP) system, QuickHire, and QuickClass and are moving to the desired service ratio of 1:82;
- Led recruitment and staffing for the Emerging Leaders Program (ELP); provided technical guidance to ELP supervisors and mentors and hired five Emerging Leaders; hired and placed thirty-one Hispanic Association of Colleges and Universities (HACU) interns who majored in various science-related/information technology fields and provided technical guidance to HACU supervisors, administrative and personnel teams; and hired and placed two Presidential Management Interns (PMI) in designated career paths;
- Provided advice and assistance, and coordination with the agency's A-76 initiative, and the agency's White Oak move including working with management officials to assure proper union participation and coordinating with various union stewards; and,
- Provided advice and guidance on FDA-wide implementation of the SSO, to include evaluation of the union's proposals, providing counterproposals, and bargaining strategy.
- Began implementation of shared services concept in accordance with Booz-Allen Hamilton (BAH) Administrative Consolidation Study; and,
- Consolidated the following administrative management functions: Personnel, Procurement, Facilities, Grants, and Information Technology.
- In support of the President Management's Agenda initiative on the Strategic Management of Human Capital, the Office of International Programs (OIP) reorganized from four staff divisions, with a total of six managers, to a streamlined office of two staff divisions and four managers;
- FDA has undertaken new initiatives to proactively engage in free trade agreement (FTA) discussions with USTR to assure that FDA's public health mission is addressed successfully so that trade in safe, effective, quality products between our country and others can be facilitated to the betterment of public health in both countries. The recent FTA with Singapore is a template for further FDA involvement in this area. These negotiations are coordinated and led by FDA's international activities program;
- Managed FDA risk management initiatives with foreign governments concerning compliance problems with foreign products, for example, food and drug safety issues related to contaminated foods that caused six separate food borne disease outbreaks in the U.S. and managed crosscutting agency technical assistance/cooperation activities to leverage resources for training foreign regulatory scientists to improve the safety and quality of FDA-regulated products exported to the U.S.; and,
- Supplemented FDA's regulatory enforcement activities by managing international agreements based on the cooperation of the exporting countries' governments and assessed the efficacy of bilateral and multilateral agreements, and worked with the Department of State, the U.S. Trade Representative (USTR), and other Federal agencies to negotiate additional agreements.
Using a strategic approach has enabled the OIP to accomplish more without additional resources. We predict in the future there will be enhanced efforts at agency-wide leveraging and we also are looking for leveraging opportunities outside FDA. The following activities were accomplished:
- Provided leadership and staff support in the U.S. - MOU on Aquacultured Molluscan Shellfish assisting the Ministries of Agriculture and Health in Mexico to rebuild the Mexican shellfish sanitation program and assure quality and safety in Mexican exported molluscan shellfish. This was the culmination of a two-year long process in working towards the resolution of a high-profile trade barrier;
- Provided both leadership and staff support to bring about closer collaboration on therapeutic products through the U.S.-Switzerland -- Regulatory Collaboration on Therapeutic Products. This MOU facilitates the exchange of information regarding pharmaceuticals and medical devices;
- Provided guidance and management of a sensitive issue when contaminated cantaloupes arrived from Mexico, which resulted in a decision to issue a country-wide DWPE (detained without physical examination) on this commodity in October 2003. FDA also facilitated communication between the U.S. Trade Representatives (USTR), Mexican officials, and the State Department on the status and aspects of this border closing in which FDA also initiated an alternate strategy to develop a technical partnership using the shellfish model as an approach to a broader collaboration within Mexico; and,
- FDA, as a result of trade discussions between USTR and Chile, worked together to get Chile to recognize FDA as the competent authority for identifying U.S. dairy firms that wanted to export to Chile.
Unified Financial Management System -- Financial Enterprise Solutions
The Financial Enterprise Solutions (FES) comprises a set of distinct and separate financial systems that are integrated with HHS' Unified Financial Management System (UFMS). The UFMS project, as directed by Secretary Thompson in his June 2001 memorandum, will integrate the financial management structure throughout the Department to provide more timely and consistent information, with the goals of providing real-time reporting and allowing for easier development of the financial statements.
Began the implementation of UFMS by performing the following tasks:
- Worked with the CDC and the Program Support Center (PSC) to develop an initial set of baseline requirements, with CDC designated as the pilot agency for UFMS with a complete implementation of the Oracle Financial's. in October 2004. In preparation for the implementation, FDA participated with the other HHS agencies in a Conference Room Pilot where the HHS Global team validated the configurations and ensured that the baseline requirements were met; and,
- Began planning for FDA's implementation of UFMS.
- Began the last phase of the Travel Manager Implementation project in preparation for UFMS by upgrading to Travel Manager Version 8.2 and implemented the system agency-wide to all the FDA components;
- Implemented the Purchase Request Information System (PRISM), which automated FDA's procurement functions, including requisitions and award processes within the simplified acquisitions and contract functions. Implemented PRISM to over 50 users in FDA Headquarters;
- Phase I of the Financial Management Reporting System (FMRS) is nearing completion. It will work to enhance and replace FDA's current reporting system and work seamlessly with UFMS and FES systems. The team worked with Headquarters' Divisions, Centers, Program Offices, and ORA Regions to document FDA-wide reporting requirements for budgetary and resource management systems such as GLAS, CFMS and any Center- or Region-specific systems;
- Designed and implemented an interface to obtain applicant data, track MDUFMA billing and collection, and provide financial reports for MDUFMA activities using Oracle's Accounts Receivable module; and,
- Performed an assessment of the Division of Freedom of Information's (DFOI) billing and collection processes and systems. Analyzed and documented DFOI's billing and collection processes and systems to help identify process improvement opportunities. Determined that Oracle Financial's. can accommodate DFOI's needs, and that the business process improvements should be implemented to ensure the new FOI billing and collection system is a success.
- Completed all preparatory work for the stand-up of the IT SSO on October 1, 2003;
- Developed Agency standards for electronic communications with industry, completed production release of the FDA Unified Registration and Listing System (FURLS), and initiated an electronic gateway submission project;
- Assessed all IT infrastructure and major systems in FDA's inventory for Federal Information Security Management Act (FISMA) compliance and provided any needed corrections; this included a Certification and Accreditation program focusing on the FDA's Critical Infrastructure Protection (CIP) inventory; a majority of the inventory will be completed in FY 03 with the remaining done by mid- FY 2004; and,
- Led the design and implementation team for HHS-Net, a network modernization effort that supports HHS-wide, applications, provides a robust network that is secure and reliable, and provides interoperability among the OPDIVs.
Office of Orphan Products Development
Since the passage of the Orphan Drug Act in 1983, the Office of Orphan Products Development (OPD) has designated 1,272 products to treat rare diseases. Two hundred fifty of these orphan products have received FDA market approval, and are now available to treat a potential patient population of more than 12 million U.S. citizens. Thirty-four approved orphan products have been developed with funding from the orphan product grant program.
- OPD received 152 applications for orphan designation during FY 2003. Based on reviews conducted by OPD medical, and pharmaceutical review staff, 90 products received designation as orphan products. Fourteen orphan products received FDA market approval for the treatment of rare diseases in FY2003. See Table below.
|List of FY 2003 Orphan Product Approvals|
|Generic Name||Trade Name||Indication|
|Ceramide trihexosidase/alpha-galactosidase A||agalsidase-beta (USAN)||Treatment of Fabry's disease|
|Buprenorphine hydrochloride||Treatment of opiate addiction in opiate users|
|Buprenorphine in combination with naloxone||Buprenorphine/naloxone||Treatment of opiate addiction in opiate users|
|Tositumomab and iodine I 131 tositumomab||Anti-B1 Ab & I-131
|Treatment of non-Hodgkin's B-cell lymphoma|
|Nitazoxanide||Treatment of cryptosporidiosis|
|Pegvisomant||Treatment of acromegaly|
|Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution||Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment|
|laronidase||rHalpha-L-iduronidase||Treatment of patients with mucopolysaccharidosis-I|
|miglustat||Treatment of Gaucher disease|
|Synthetic porcine secretin||For use in the evaluation of exocrine pancreas function|
|porfimer||For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients who are not considered to be candidates for esophagectomy|
|nitazoxanide||Treatment of intestinal giardiasis|
|ribavirin||Treatment of chronic hepatitis C in pediatric patients|
|bortezomib||To treat multiple myeloma|
Office of Pediatric Therapeutics
- Worked with CDER in implementing the safety monitoring mandated by the Best Pharmaceuticals for Children Act; and,
- Participated in an informational program sponsored by the National Institute of Child Health and Human Development (NICHD) to update the other NIH Institutes on implementation of the BPCA.
Office of Combination Products
Under MDUFMA, FDA established the Office of Combination Products (OCP) within the Office of the Commissioner's Office of International Activities and Strategic Initiatives on December 24, 2002. This legislation established broad responsibilities for OCP that cover the entire regulatory life cycle of drug-device, drug-biologic, device-biologic, and drug-device-biologic combination products, and include oversight of product jurisdiction decisions and specific premarket review and postmarket processes.
The OCP received 16 requests for assignment of products determined to be combination products in FY 2003, 10 of which were determined to be drug-device combinations, two were device-biologic combinations, and one was a drug-biologic combination. All of the assignments due as of September 30, 2003 were issued within the required 60-day period.
* Total does not include one request for reconsideration that was responded to within 15-day timeframe provided in 21 CFR § 3.8
**Two applications were withdrawn.
|Assignment of Combination Products
December 24, 2002 through September 30, 2003
|Total Requests for Assignment Submitted*||Assignments
|Issued on Time (%)|
- Began developing an internal database of Request for Designation determinations to facilitate the timely consideration of new assignment requests.