|FY 2005 Actual||FY 2006 Enacted1||FY 2007 Estimate||Increase or Decrease|
|Program Level||$104,504,000||$117,414,000||$120,341,000||+ $2,927,000|
Cost of Living
Budget Authority FTE
Total User Fees
User Fee FTE
1 Includes the rescission of 1 percent.
|Fiscal Year||Program Level||Budget Authority||User Fees||Program Level FTE|
Statement of Budget Request
The Other Activities program is requesting $120,341,000 in program level resources for accomplishing its mission activities including:
- Providing 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.
- Providing management expertise and direction to support standards development for regulated products to effectively serve consumers and our industry stakeholders.
- Developing agency-wide policy in legislation, consumer communications, public information, scientific coordination and regulatory requirements.
- Providing direction in the management of financial, human and information systems resources, knowledge management and other critical infrastructure needs in support of our science-based work.
Through the Office of the Commissioner, Other Activities provides agency-wide program direction and administrative services to ensure that FDA's consumer protection efforts are effectively managed and that available resources are put to the most efficient use. The Office of the Commissioner consists of nine subordinate offices that provide policy making, program direction, coordination and liaison, and expert advice to agency leadership and programs. The following table provides a description of each office's functions.
|Office of the Chief Counsel||Provides expert legal advice and review on statutory and regulatory interpretations affecting FDA enforcement and administrative actions.|
|Office of Crisis Management||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, and internal and external security.|
|Office of Equal Employment Opportunity and Diversity Management||Advises and assists key officials on equal employment opportunity (EEO) and Civil Rights activities; develops, implements, and monitors the FDA's Affirmative Employment Plan and directs the Affirmative Employment Program; develops labor-management partnerships on EEO matters; and develops and oversees diversity initiatives.|
|Office of External Relations||Advises FDA leadership on activities and issues affecting FDA programs, projects, and strategies impacting on various constituencies - including the public, consumer groups, industry and trade association, stakeholders, and governmental bodies.|
|Office of International Affairs and Strategic Initiatives||Advises FDA leadership on international activities including the coordination of the international conference on harmonization and World Health Organization functions; and fosters the development of and administers mutual recognition agreements and other policy documents with foreign countries and multi-national governmental organizations. The office also administers the combination products and pediatric therapeutics programs.|
|Office of Legislation||Coordinates FDA's response to authorizing committees' requests, reviews proposed legislation, prepare agency testimony and facilities clearance by the Department and OMB.|
|Office of Management||Provides variety of administrative and program support services, assures strategic and operational management of information technology, financial management expertise, and administrative support services to FDA employees.|
|Office of Planning and Policy||Provides advice and assistance in policy development and oversees FDA rulemaking; serves as focal point for coordinating agency strategic, performance and business-process planning and evaluation; ensures that internal and external stakeholders clearly understand FDA's challenges, achievements, and future directions.|
|Office of Science and Health Coordination||Advises key officials on scientific issues that impact policy, direction, and long-range goals; coordinates the responsibilities for women's health issues, good clinical practices program, and orphan product development program.|
During the latest performance period, (FY 2005), the Other Activities Program met the targets for all four performance goals. For more information about these performance goals and results, please see the Performance Detail section.
The FDA supports the Department in establishing a Unified Financial Management System (UFMS). The goal of the UFMS project is to reduce costs, mitigate security risks, and provide timely and accurate information across DHHS. Implementing a new financial system will provide qualitative and quantitative benefits to FDA because it will achieve improved business processes and provide more accurate and timely information to better support FDA's and DHHS' mission.
|FY 2007 Goal Target||FY 2005 Results||Context|
|Through FDA's implementation of HHS's Unified Financial Management System, the FDA will finalize its decision on an activity-based costing application and make it operational for its user fee programs.||Major components of data cleanup have been completed. Travel Manager implementation has been completed throughout the Agency in preparation of UFMS.||FDA is complying with the department's goal to establish a unified financial management system. Specifically, the Department plans to utilize two accounting systems: one for the Center for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, and one serving the National Institute of Health (NIH), the Program Support Center (PSC) and its eight servicing OPDIVs, the Center for Disease Control andPrevention (CDC) and FDA.|
Program Resource Changes
Pandemic Preparedness: + $ 2,354,000
FDA plays a unique and vital role in the Nation’s preparedness for an influenza pandemic. The agency facilitates the development and availability of safe and effective vaccines and we safeguard America’s animal health and food safety systems in the event of an outbreak of avian and pandemic influenza. This funding will enhance the Agency’s crisis management office located in the Other Activities program to coordinated the Agency’s preparedness efforts and provide the necessary coordination to respond to a pandemic influenza outbreak.
Food Defense: + $1,485,000 and + 2 FTE
The food supply is part of the Nation's critical infrastructure and contributes about 20 percent to the U.S. Gross National Product. A terrorist attack on the food supply could have catastrophic public health and economic consequences. The funds requested would continue to enhance laboratory preparedness, food defense research, surveillance and incident management capabilities. These enhancements would expand FDA's capacity to prevent, prepare for, respond to and mitigate the effects of a terrorist attack, a major disaster or other emergency on the food supply. The Other Activities program component of this initiative is $1,485,000 and 2 FTE.
Improved Drug Safety: + $ 396,000 and + 2 FTE
This initiative will enable FDA to continue its efforts to transform healthcare by reducing occurrences of drug side effects and increasing the number of more affordable drug treatment options. Specifically, funding for this initiative will make possible our continued efforts to modernize the Adverse Event Reporting System (AERS) to create "AERS II", the primary source for drug product adverse event data. To further augment AERS data, FDA will advance its integration efforts with the Centers for Medicaid and Medicare (CMS) to obtain access to very valuable drug safety information housed in CMS population-based databases. The initiative is $3,960,000 and 8 FTE. The Other Activities' share is $396,000 and 2 FTE.
Cost of Living-Pay: + $1,413,000
FDA's request for pay inflationary costs is essential to accomplishing its public health mission. Payroll costs account for over sixty-percent of our total budget, and the Agency is no longer able to absorb this level of inflation on such a significant portion of its resources. The increase will allow FDA to maintain staffing levels, including a national cadre of specially trained scientific staff. The total estimate for pay increases is $20,267,000. The Other Activities' portion of this increase is $1,413,000. These resources are vitally important for FDA 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.
Unified Financial Management System: +$1,180,000
- Support to the UFMS Global Program Management Office and the Operations and Maintenance Center of Excellence in all testing activities associated with new releases.
- Support for system enhancements and updates.
- Training for new and current users throughout the Agency.
- Vendor support for reporting tools and licenses.
- Ongoing stabilization efforts in FY 2007.
Other Activities Reduction: - $5,497,000 and - 19 FTE
To fund FY 2007 priority initiatives such as activities such as Pandemic Preparedness, Food Defense, and Drug Safety, the Other Activities program will reduce the number of the FTE through attrition, selective replacement of vacant positions, and other workforce restructuring strategies.
Prescription Drug User Fee Act: +$1,156,000 and + 3 FTE
PDUFA authorized FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review. These fees expand the resources available for the process of reviewing human drug applications including reviewers, information management, space costs, acquisition of fixtures, furniture, equipment and other necessary materials so that safe and effective drug products reach the American public more quickly. In 2002, the Bioterrorism Act included reauthorization 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 (PDUFA III). The reauthorization directs 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. In FY 2007 FDA will work with Congress on the reauthorization of the Prescription Drug User Fee Act. This increase of $1,156,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act.
Medical Devices User Fee and Modernization Act: +$386,000 2 FTE
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002 and was amended by the Medical Device User Fee Stabilization Act of 2005. MDUFMA has three particularly significant provisions. These provisions allow for the collection of user fees for premarket applications, allow establishment inspections to be conducted by third parties and place new regulatory requirements on reprocessed single use devices. The revenues from these fees, and the appropriated trigger amounts will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. In FY 2007 FDA will work with Congress on the reauthorization of the Medical Device User Fee and Modernization Act. This increase of $386,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act.
Animal Drug User Fee Act (ADUFA): + $50,000
The Animal Drug User Fee Act of 2003 (ADUFA) amends the Federal Food, Drug and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications. ADUFA helps the FDA, through a strengthened animal drug pre-market review program, to provide greater public health protection by ensuring that animal drug products that are approved to be safe and effective are readily available for both companion animals and animals intended for food consumption. Additional resources provided by ADUFA will also help FDA scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for our animals. ADUFA will help provide a cost-efficient, high quality animal drug review process that is predictable and performance driven. In FY 2007 FDA will work with Congress on the reauthorization of the Animal Drug User Fee Act. This increase of $50,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act.
Mammography Quality Standards Act (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, which was reauthorized in October 2004, addresses the public health need for safe and reliable mammography. The Act required that mammography facilities be certified by October 1994, and inspected annually to ensure compliance with national quality and safety standards. The reauthorization codified existing certification practices for mammography facilities and laid the groundwork for further study of key issues that include ways to improve physicians' ability to read mammograms and ways to recruit and retain skilled professionals to provide quality mammograms. The increase of $4,000 will cover inflation.
Proposed User Fee Proposals
Reinspection User Fee (Mandatory): + $7,100,000 and + 16 FTE (Non-Add)
The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $22.0 million in revenue, an amount sufficient to fully fund reinspections. The Other Activities program component of this user fee is $7,100,000 and 16 FTE.
Justification of Base
Base resources support a many critical activities servicing various stakeholders (DHHS, OMB, Congress, and others) and agency components. The following activities are arrayed by FDA strategic goal.
FDA Strategic Goal: Enhancing Patient And Consumer Protection and Empowering Them with Better Information about Regulated Products
Base resources supports the strategic goal by planning and preparing for emergency events; monitoring the integrity of clinical research to ensure adequate human protection; promoting outreach programs that explain consumer choices for better health; and ensuring that women's needs are considered in the review of FDA-regulated products.
Emergency Response and Preparedness
FDA must have the capability to assess and effectively prepare for and respond to public health emergencies and other incidents known or suspected to be terrorist-related. The Agency plays a vital role in homeland security through measures to safeguard regulated food and medical products from attack and to speed the availability of medical countermeasures. The unpredictable and varied ways acts of terror can be launched complicate preparedness and the agency's ability to respond quickly and effectively. As a result, FDA is developing a robust system to manage incidents. The Agency also is expanding the exercise program that periodically tests our response capabilities.
FDA has several major objectives that address these challenges:
- Enhance public protection against the effects of a terrorist attack by facilitating the development and use of safe and effective medical countermeasures. For example, assist DHHS with Project Bioshield and the Strategic National Stockpile.
- Implement and enhance procedures for Emergency Use Authorization (EUA) requests including proactive review of candidate products before an emergency to expedite availability in crisis situations.
- Enhance the security of America's food supply by enhancing food defense preparedness and research. For example, implement key provisions of the Bioterrorism Act including prior notice of imported foods, registration of certain types of food facilities, records maintenance, and administrative detention.
- Improve prevention and detection of product tampering through development and use of needed methodologies.
Consumer Out-Reach and Education Programs
FDA directs an array of public outreach programs to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products. These activities include:
- Development and implementation of an FDA-wide consumer communication infrastructure and consumer-media outreach strategy to help both consumers and patients understand how to live better, healthier lives.
- Create and leverage collaborations with healthcare providers, and public and private healthcare organizations and institutions.
- Seek out speaking opportunities for FDA to communicate directly with diverse consumer segments.
Good Clinical Practice Program
This program is the focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human research trials regulated by FDA. To improve and enhance protection for human subjects, the Program:
- Coordinates FDA policies, develops guidance, and provides advice on HSP and GCP.
- Provides leadership and direction through the administration of FDA's Human Subject Protection/Good Clinical Practice Steering Committee.
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials.
- Contributes to international GCP harmonization activities.
- Plans and conducts training and outreach programs for internal and external audiences.
- Serves as FDA's liaison with the HHS Office of Human Research Protection and other federal agencies and external stakeholders committed to the protection of human research participants.
- Contributes to the HSP/Bioresearch Monitoring Steering Committee's initiative to implement a quality systems framework for the agency's GCP activities and Bioresearch Monitoring program.
Office of Women's Health
The Office of Women's Health works to identify key agency priorities regarding women's health and sex differences and to effectively deliver health messages to women around the nation; and develops partnerships and collaborations with stakeholder organizations to best facilitate outreach and consumer information dissemination. These partnerships have resulted in unprecedented free publicity for and duplication of millions of FDA/OWH materials using a variety of media venues (e.g., print, radio, television). Specifically, OWH continues to:
- Develop and disseminate consumer and health provider information about FDA regulated products that will result in improved health for consumers including women.
- Conduct outreach campaigns related to menopause and hormone therapy and roll out developing campaigns in cardiovascular disease, health fraud and safe medication use.
- Update the OWH website with current products, contacts, and information.
Science and Health Coordination Responsibilities
- Manages two OC advisory committees, the FDA Science Board, the Senior Science Council and the Committee for the Advancement of FDA Science.
- Manages the FDA Research in Human Subjects Committee and Quality Assurance Program.
- Coordinates standards development and science initiatives across agency.
- Manages the annual Science Forum.
- Serves on several interdepartmental committees of OSTP addressing scientific issues.
- Coordinates Commissioned Corps activities for the FDA, oversees implementation of Corps transformation for FDA, implements Corps policy and regulations for FDA's 700-plus officers and serves as the FDA representative to the Surgeon General's Policy Advisory Council.
FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health
Base resources support the strategic goal by ensuring administration of two statutorily established programs addressing combination products and pediatric drugs.
Office of Combination Products
The Office of Combination Products (OCP) is a statutorily mandatedOffice with wide-ranging and specific regulatory responsibilities to ensure the consistent and appropriate assignment, premarket review and postmarket regulation of combination products. OCP responsibilities cover the regulatory life cycle of combination products, and oversight of product jurisdiction decisions and specific premarket and postmarket processes. Its responsibilities directly contribute to FDA's strategic goals to (1) increase access to innovative technologies to advance health, (2) improve product quality and safety through better manufacturing oversight, and (3) expand patient protection and empower consumers for better health. OCP activities include:
- Conducting the FDA product jurisdiction program.
- Facilitating the timely and effective premarket review of combination products.
- Ensuring consistent and appropriate postmarket regulation of combination products.
- Developing cross-cutting regulations, guidance documents, procedures and processes to clarify the regulation and assignment of combination products.
- Serving as FDA's focal point on matters related to combination products for internal and external stakeholders.
Office of Pediatric Therapeutics
The Best Pharmaceuticals for Children Act directed HHS to establish an Office of Pediatric Therapeutics within FDA's Office of the Commissioner. The Pediatric Research Equity Act of 2003 authorizes FDA to require pediatric studies and establish a Pediatric Advisory Committee. The Office of Pediatric Therapeutics has five areas of responsibility: pediatric ethics, safety review and reporting for certain pediatric products, agency-wide scientific coordination, external communications, and the Pediatric Advisory Committee. Office activities include:
- Overseeing the safety of all drugs granted pediatric exclusivity.
- Enhancing the ethical conduct and quality of pediatric clinical trials.
- Assuring ethical pediatric research and child subject protection across all FDA centers.
- Reviewing, evaluating and advising on Subpart D (additional protections for children) referrals from Institutional Review Boards.
- Developing cross-cutting pediatric scientific issues and coordinate activities pertaining to the pediatric population across all FDA product Centers.
- Enhancing communication of pediatric issues and new pediatric information for FDA regulated products with consumers, advocacy groups, and healthcare providers.
- Serve as the pediatric liaison to external organizations.
FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century
Base resources support this strategic goal by providing administrative policy, support and delivery of services to FDA components.
Shared Services Activities
The Office of Shared Services and Office of Information Technology Shared Services provide a portfolio of administrative and information technology services to components agency-wide. The shared services concept employs innovative management techniques such as customer advocacy, negotiated service level agreements, engaged performance planning, active governance boards and integrated strategic planning that leverages the best of centralized and decentralized organization structures. Key activities include:
- Providing advisory services to program and management personnel in the business and administrative aspects of the contracting program.
- Managing contracts, grants, purchase card and interagency agreement programs.
- Performing day-to-day operations for financial services related to accounts payable, travel payments, invoice payments, payroll, fleet and claims management.
- Directing the management of programs and systems leading to the acquisition, alteration, maintenance, and utilization of leased and owned facilities nationwide.
- Directing building operations functions for all FDA facilities nationwide.
- Providing medical library services to FDA employees.
- Providing consolidated management of all common IT infrastructure organizations across the agency as required under the Clinger-Cohen Act of 1996 and HHS "One Department" goals.
- Operating a modern contact center (Employee Resource and Information Center) to provide information and services to over 10,000 employees nationwide for obtaining a wide array of administrative and IT assistance.
FDA financial systems support all agency financial activities and are mission critical needs for our public health mission. Improved financial performance includes initiatives to reduce erroneous payments and roll-out an activity based cost application for FDA's user programs. FDA moved into an environment that resolved outstanding audit findings, met modern Federal financial requirements, maintained a clean audit opinion, and provided timely financial information to support strategic and resource allocations. These activities include:
- Monitoring and ensuring that financial operating plans and budget execution reports meet Federal requirements while providing timely financial information to Agency leadership.
- Formulating user fee projections used in the budget submission; execute and monitor user fees resources that were provided to FDA programs; report annually on agency expenditures to the Congress.,
- Preparing quarterly financial statements and annual financial reports, and liaison with the Office of Inspector General's independent auditor conducting the audit on FDA's financial statements, and perform necessary audit follow-up.
User Fees Programs: Prescription Drug User Fee Act (PDUFA), Medical Devices User Fee and Modernization Act (MDUFMA), Animal Drug User Fee Act (ADUFA), and Mammography Quality Standards Act (MQSA)
The Other Activities share of the user fee programs provides the financial management infrastructure for the collection, receipt, payment, accounting, and reporting of user fee revenues and expenses for PDUFA, MDUFMA, ADUFA, and MQSA. It also coordinates the acquisition and management of the additional space, and provides information technology support.
Other Activities coordinates the preparation of the annual fiscal report to the Congress for PDUFA, MDUFMA, and ADUFA, and is also responsible for the annual PDUFA performance report to Congress and for assisting with other management responsibilities including the PDUFA III goal for improved performance management and the various associated contracts.
FDA management programs support the agency by providing specialized workforce programs, administering the FDA ethics program, implementing programs on the Privacy Act, Freedom of Information Act, and Paperwork Reduction Act, and providing management analysis support to the Office of Commissioner. FDA management programs provide leadership and direction regarding all aspects of a variety of essential agency management programs. These activities include:
- Managing the agency Ethics program to ensure that all FDA employees are in compliance with regulations to maintain high standards of ethical conduct.
- Coordinating the implementation of the Federal Manager's Financial Integrity Act in the agency and preparing the annual assurance statement that internal controls are providing reasonable assurance against waste, fraud, and abuse.
- Acting as liaison with the Department's Office of Inspector General regarding the conduct of audits and evaluations, and providing coordination of agency responses to audit reports and audit follow-up.
- Directing FDA's organizational management and delegations of authority program in conformance to government-wide regulations and departmental policies.
- Establishing and overseeing implementation of the FDA policy, procedures and processes to ensure agency conformance with the Paperwork Reduction Act.
- Providing leadership and direction to FDA's Freedom of Information (FOI), Privacy Act, and regulatory dockets and rule-making activities.
- Overseeing the agency's competitive sourcing (A-76) program.
- Conducting specialized workforce planning and development programs including the Quality of Work Life, Reward & Recognition, Performance Management, Scientific and Regulatory Peer Review Program.
- Acting as liaison with the Commissioned Corps and the Department's Human Resources Offices to ensure FDA personnel issues are addressed.
FDA's Information Technology (IT) program enables FDA's strategic efforts by transforming and improving the systems and infrastructure needed to support critical agency operations. Specific initiatives of the program include:
- Consolidating and modernizing the FDA's IT infrastructure thereby ensuring a stable and robust environment for critical health initiatives such as Health Information Technology (HIT) that rely heavily on IT to operate effectively.
- Enhancing the implementation of enterprise-wide management systems, including integrated data warehousing of financial and program performance information through the alignment of financial information with program and FDA performance measures.
- Optimizing data and systems security measures to strengthen the reliability, integrity, survivability, and continuity of all FDA information technology operations.
- Providing support and tools for ongoing business process planning by making available IT management and technical expertise across FDA programs.
- Maximizing the availability and use of information technologies that increase or enhance electronic access for the public, as well as for the full span of FDA external and internal customer base, while maintaining security by achieving the E-Gov goals of the PMA in a fashion that meets FDA business needs.
- Aligning IT investments to business goals in a manner that reduces costs of existing legacy systems by ensuring the FDA IT Portfolio effectively aligns and fully supports core mission and business priorities.
OC Information Technology Initiatives
- Office of Women's Health Demographic Information and Data Repository Development (DIDR) Program - The DIDR Program is an information management system to develop new systems for the collection of demographic data in clinical studies submitted to the Agency. The system will eventually allow for an Agency wide information management infrastructure intended to improve the analysis and reporting of subpopulation data (e.g., sex, race, ethnicity and age) in clinical trials and product labeling. This program requires the creation of additional electronic warehouses, standards for electronic submission of data, standards for reviewer analysis and templates for reviews that can feed directly into a database that can provide the basis for demographic data analyses across studies, products, and Centers. Specifically, the program will:
- Continue the CDER pilot of a "SMART" document approach to select reviews.
- Expand the "SMART" document approach to other CDER and CBER review templates.
- Continue development and testing and explore storage and reporting components of the Template Warehouse System.
- Prepare report to CDER on findings of the pilot "SMART" document program.
Enterprise Information technology Fund
The Food and Drug Administration's request includes funding to support the President's Management Agenda Expanding E-Government and Departmental enterprise information technology initiatives. Operating Division funds will be combined to create an Enterprise Information Technology (EIT) Fund to finance specific information technology initiatives identified through the HHS strategic planning process and approved by the HHS IT Investment Review Board. These enterprise information technology initiatives promote collaboration in planning and project management and achieve common HHS-wide goals. Examples of HHS enterprise initiatives funded by the EIT Fund are Enterprise Architecture, Capital Planning and Investment Control, Enterprise E-mail, Grants Management Consolidation, and Public Key Infrastructure."
Research, Development, and Evaluation (RD&E) Activities
The Office of Women's Health Scientific Research Program addresses gaps in current knowledge, uses novel approaches for conducting research, and sets new standards of excellence for women's health research. The program funds research projects at FDA and academic institutions through intramural and extramural research programs and special funding initiatives. Some of the program's key activities include:
- Using a peer review process to select the highest quality scientific research projects of regulatory significance to FDA.
- Implementing a process to identify the women's health research needs of highest priorities in the Centers to advance a science program, including the review and awarding processes, that directly reflects these priorities and integrates them with the Critical Path Initiative.
- Partnering with other HHS organizations to identify gaps in women's health research and to leverage current funding to best fill those research needs.
- Seeking out opportunities to present the OWH scientific programs and facilitate discussion in cross cutting women's health scientific issues and research needs.
- Updating the OWH Pregnancy Registry website with current information.
Selected FY 2005 Accomplishments
FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products
Office of Counterterrorism Policy and Planning
FDA's Office of Counter Terrorism Policy and Planning serves as FDA's focal point for the development and implementation of policies that safeguard food and medical products from intentional adulteration or disruption of supplies, and policies to facilitate the availability of safe and effective medical countermeasures. Specific accomplishments include:
- Issued the Draft Guidance on Emergency Use Authorization of medical countermeasures during declared emergencies involving a heightened risk of attack.
- Coordinated issuance of an Emergency Use Authorization to DoD for the use of the Anthrax Vaccine Adsorbed.
- Ensured that recommendations of the Weapons of Mass Destruction Medical Countermeasures Senior Steering Committee on purchases for the Strategic National Stockpile are based on sound information, reflect FDA professional judgment and expertise, and are consistent with FDA policies and regulations.
- Provided scientific and policy expertise while serving as an ex officio member of the National Scientific Advisory Board on Biosecurity.
- Led the development and implementation of crosscutting counterterrorism policies, such as FDA's portion of the Interagency Security Plan and the National Infrastructure Protection Plan.
Office of Women's Health
- Supported five new and fourteen continuing intramural research projects of relevance to women's health and sex differences.
- Supported one new and twelve continuing extramural research projects addressing issues related to FDA products and women's health and sex differences.
- Conducted three site visits and two Office of Inspector General audits at OWH funded institutions to ensure extramural funded studies are consistent with contractual and human subjects protection obligations.
- Continued the Take Time to Care Campaign, a multi-faceted campaign that focuses on dissemination of health education materials for consumers through activities and collaborative partnerships. A Dear Abby announcement generated 2.2 million requests for this information.
- Implemented Phase 2 of the Menopause and Hormones Education Campaign to bring clear and useful information to women about the use of hormones during menopause. This program reached approximately 15.1 million English and Spanish speaking women (ages 40 to 59) via newspaper, magazine, radio, Internet, and mass e-mail.
- Increased the frequency of distribution of the OWH E-newsletter from 4 to 6 times per year to our network of stakeholder organizations.
- Participated on thirty-two national medical, scientific, and health care conferences with an estimated outreach of 225,000.
- Translated OWH consumer information and publications into fourteen different languages.
Other Office of Science and Health Coordination Accomplishments
- Committee for the Advancement of FDA Science. Conducts twenty-four meetings per year; reports to the Council for Environmental Quality. Represents the agency on OSTP Committees on nanotechnology, deemed export, science in food and agriculture modernizing NEPA.
- Management of Agency Institutional Review Board (RIHSC) and Quality Assurance Program. These activities included approximately 200 protocols submitted for initial review, about 250 protocols submitted for continuing review, twelve meetings of the FA IRB, approximately five requests for audits of ongoing studies, 150 information requests/consultations on various human subject protection issues by the Centers.
- Management of OC Advisory Committees. The scientific peer review of the ORA pesticide program was completed, two meetings of the Science Board were held, and 5-6 meetings of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee. For each Committee, annual reports to Congress were submitted.
- Coordinating with the Office of the Surgeon General FDA's Commissioned Corps response to public health emergencies. FDA deployed over 500 Commissioned Corps officers to respond to Hurricanes Katrina and Rita, the largest number of officers from any of the Public Health Service agencies and almost 75% of FDA's total Corps strength.
- 2005 Science Forum. There were over 2000 attendees, including 200 from industry and academia; 450 posters with about 65 from non-FDA participants.
- Coordination of Standards Development Across Agency. The OSHC Director attended 4 meetings of the Interagency Committee on Standards Policy, three meetings of the ANSI Board of Directors and three of the ANSI Government Members Council, four meetings of the FDA Standards Committee, coordinated sixballots on voluntary standards, and published the annual report to Congress on FDA utilization of voluntary standards in lieu of government unique standards.
- Coordination of Science Initiatives, Science Training and Science Information Across Agency. This activity included developing initiatives on nanotechnology and genomics; discussion of FDA-wide issues through the Senior Science Council and Leadership Council.
Good Clinical Practice Program
- Published a draft guidance document, Guidance for Industry on Using a Centralized Institutional Review Board Process in MultiCenter Clinical Trials.
- Co-organized a public hearing under 21 CFR Part 15 to obtain input on adverse event reporting to Institutional Review Boards in order to develop guidance for industry on this issue.
- Conducted numerous Good Clinical Practice and Human Subject Protection Education and Outreach Programs.
- Developed and continued to maintain the agency Clinical Trials/Good Clinical Practice webpage for research professionals.
- Responded to over 1500 queries annually received in a dedicated GCP e-mail account or by telephone, and implemented a Katrina clinical trials hotline.
- Contributed to international working groups on good clinical practice (GCP) and human subject protection (HSP) projects.
- Participated as FDA representative to the (1) US-China Health Care Forum; and (2) Clinical Trials Congress.
FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health
Office of Combination Products
The Office of Combination Products directly contribute to FDA's strategic goals to (1) increase access to innovative technologies to advance health, (2) improve product quality and safety through better manufacturing oversight, and (3) expand patient protection and empower consumers for better health. Specific accomplishments include:
- Issued 37 decisions in response to formal Requests for Designation (RFD) under the agency's product jurisdiction program. The average RFD review time was 42.9 days of the 60 days provided by statute, and 100 percent of the decisions were issued on time.
- Published a final rule defining the primary mode of action of a combination product.
- Responded to over 195 stakeholder inquiries on issues ranging from the assignment process itself to jurisdictional issues on a wide range of specific combination products.
- Facilitated the premarket review process for a wide variety of combination products presenting complex regulatory issues.
- Published three final guidance for industry and agency review staff: Application User Fees for Combination Products; Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product; and How to Write a Request for Designation (RFD).
- Monitored and actively facilitated 275 inter-center consulting requests for combination products to ensure the requesting center received timely and effective feedback. This represents a 31% increase over FY 2004.
Office of Pediatric Therapeutics (OPT)
- Reviewed and presented fifty products studied in children to the Pediatric Advisory Committee (PAC) in a public forum as of November 2005.
- Provided advice and consultation on ethical issues across the agency and to external stakeholders.
- Developed, with the Department's Office for Human Research Protection (OHRP), a collaborative Subpart D process to address the ethical issues of testing drugs in children.
- Coordinated and participated in international pediatric regulatory activities
|February 2005||June 2005||November 2005|
|Lotensin (benazepril)||Arava (leflunomide)||Imitrex (sumatriptan)|
|Malarone (atovaquone/proguanil)||Concerta (methylphenidate)||Camptosar (itinotecan)|
|Brevibloc (esmolol)||Zemplar (paricalcitol)||Carboplatin (paraplatin)|
|Viracept (nelfinavir)||Zomig (zolmitriptan)||Vioxx (rofecoxib)|
|Xenical (orlistat)||Ortho-Tri-Cyclen (ethinyl estradiol; norgestimate)||Ferrlecit (sodium ferric gluconate)|
|Gluvovance (glyburide/metformin)||Cipro (ciprofloxacin)||Diflucan (fluconazole)|
|Trusopt (dorzolamide)||Tamiflu (oseltamivir)|
|Detrol (tolterodine)||Agrylin (anagrelide)|
FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century
- Supported implementation of the Unified Financial Management System (UFMS) and iProcurement.
- Implemented grant processing system eRA/IMPAC II.
- Met HHS goal for electronic posting of federal grants applications on grants.gov.
- Met HHS small business contracting goals.
- Reduced misuse and delinquencies on travel card purchases.
- Improved vendor payment processes.
- Implemented facility management system.
- Created the Division of Logistics Services to provide facilities services to the FDA White Oak Campus.
- Implemented processes to improve timeliness of service ticket resolution.
- Completed implementation of the financial management user fee solution. These included PDUFA, MDUFMA, ADUFA, MQSA, Color certification, and export certification payment information.
- Completed the implementation of the Purchase Request Information System (PRISM)
- Completed the FDA Federal Activities Inventory Reform (FAIR) Act of 1998, which identified 1,495 FTE as commercial and 8,815 FTE as inherently governmental.
- Completed development of the Most Efficient Organization (MEO) for the 350 FTE Clerical Support Services Study with a performance decision announced in February 2005 awarding the competition to the FDA's MEO. A formal transition process began in May 2005 with the expectation that the MEO will be operational by the second quarter of FY 2006.
- Commenced on October 1, 2004, the Single Source Infrastructure Service Support which consolidated 15 IT Infrastructure Service contracts, which will result in nearly $10 million in savings over the next five years.
- Awarded the contract to develop the Electronic Submissions Gateway (e-Submissions Gateway), which will provide a single point of entry for electronic regulatory submissions to the FDA.
- Awarded the contract to implement electronic standards for structured product labeling (SPL).
- Led, as project manager, the HHS-Net project by designing the solution and directing the successful implementation across all Operating Divisions.
- Partnered with HHS to achieve an Enterprise Email Systems (EES) design that met both HHS and FDA-specific needs and began the conversion project.
- Provided HHS with a proven model for an HHS-wide tool (Prosight) for Capital Planning and Investment Control (CPIC) process.
- Fully met HHS SecureOne Goals (100 percent C&As and PIAs accomplished; 100 percent employees received IT security training).
- OMB recognized FDA as one of the lead federal EA programs with a Level 3 maturity rating; FDA also received the Excellence in Enterprise Architecture Award for its leadership in this area.
- Achieved greater than 25% reduction in last year's FISMA reportable conditions, and have no significant deficiencies; commended by the IG for a strong security posture within HHS, as exemplified by performance in combating the Zotob worm, in which we were able to report no incidents.
- Successfully implemented automated patch management this year, and now have the capability to "push" new software and patches onto 100% of FDA desktops in order to ensure a standard configuration.
- Fully tested Disaster Recovery Plan by September 30, 2005.