Other Activities

	FY 2000 Actual	FY 2001 Appropriation	FY 2001 Current Estimate ^{1/, 4/}	FY 2002 Estimate^3/	FY 2002 +/- FY 2001 Current Estimate
Total Program Level ^2/FTE	$78,120,000 783	$79,020,000 774	$78,873,873 774	$94,796,000 787	+$15,923,000 + 13
Total Budget Authority^2/ Pay Increases BSE Imports/Inspections Patient Safety/AERS Human Subject Protect. Food Safety Management Priorities	$66,601,000	$66,878,000	$66,731,000	$80,666,000	+$13,935,000 +3,235,000 + 300,000 +300,000 + 400,000 +300,000 +100,000 + 8,300,000

			274,000 20,557,000 2,889,000 1,563,000 20,700,000 0	574,000 20,857,000 3,289,000 1,863,000 20,800,000 8,300,000
Total User Fees PDUFA MQSA	$11,519,000 11,353,000 166,000	$12,142,000 11,961,000 181,000	$12,142,000 11,961,000 181,000	$14,130,000 13,944,000 186,000	+ $1,988,000 +1,983,000 + 5,000

^1/ Reflects the enacted levels adjusted for the 0.22 rescission, accounting for $148,000 in the Other Activities Program.
^2/ Reflects increase in base funding from FY 2001 of $1,000,000, for Human Subject Protection & Bioterrorism.
^3/ Pay increases are shown on separate line and not reflected in individual program areas.
^4/ The FY 2001 Current Estimate for Other Activities in the following activities (BSE, Imports/Inspections, Patient Safety/AERS, Human Subject Protection, and Food Safety) was determined by a formula that reflects Other Activities as a percentage of the total FY 2000 FDA budget.

Historical Funding and FTE Levels

Fiscal Year	Program Level	Budget Authority	User Fees	Program Level FTE
1998 Actuals	$89,824,000	$78,669,000	$11,155,000	957
1999 Actuals	$84,639,000	$74,615,000	$10,024,000	905
2000 Actuals	$78,120,000	$66,601,000	$11,519,000	783
2001 Current Estimate	$78,873,000	$66,731,000	$12,142,000	774
2002 Estimate	$94,7961,000	$80,666,000	$14,130,00	787

MISSION

Provide 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.
Provide Agency-wide policy development in medical affairs, scientific coordination, regulatory requirements, legislation, planning and evaluation, consumer communications and public information.
Provide 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. Specific programs include Freedom of Information Act activities, administration of internal controls required under the Federal Managers' Financial Integrity Act, the Small Business Program to assist businesses in carrying out regulatory requirements, and participating in FDA's regulatory decision-making process.

REQUESTED INCREASES

Pay Increase + $3,235,000

FDA’s request for funds to cover pay cost increases is vital to the Agency because personnel are so essential to accomplishing its mission. Pay increases have a major impact on FDA because the Agency is more people-intensive than many other government agencies. Payroll accounts for over 60 percent of the total FDA budget. This has a significant impact on all activities in FDA, particularly the field. The costs of the pay increases are necessary to ensure the integrity of the Agency's work through the oversight and coordinating functions of the Other Activities program.

In order to maintain the level of activities carried out in FY 2001, FDA is requesting $40,000,000 million to cover the cost of the FY 2002 pay raise, annualization of the FY 2001 pay raise, anticipated within grade increases, and one extra day of pay. The Other Activities program portion of this increase is $3,235,000. The cost of living absorption reduces the FTE available to support the Agency’s core activities.

Bovine Spongiform Encephalopathy (BSE) + $300,000 and 2 FTE

To protect consumers, it is essential that a multi-layered safeguard system be implemented and monitored to ensure that BSE regulations are followed. Many products regulated by FDA contain banned substances that could lead to BSE disease. Hence, it is important to establish and fully support a comprehensive monitoring system to identify products that may pose a health risk and ensure that they do not enter the U.S. The Office of Chief Counsel (OCC) will use the additional $300,000 and 2 FTE to do the following:

Provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations; and,
Provide litigation support for enforcement, defensive and third party matters.

Patient Safety/AERS + $400,000 and 3 FTE

FDA must continue to target resources that will develop and enhance surveillance of FDA regulated products to identify harm resulting from use of products; understand harm through expert analysis; and prevent harm to other patients by taking action. The requested funds will provide an increase of $400,000 and 3 FTE to the Office of Chief Counsel to:

Provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations; and,
Provide litigation support for enforcement, defensive and third party matters.

Human Subject Protection + $300,000 and 2 FTE

The funds requested in the FY 2002 budget will provide legal support in the Office of the Chief Counsel to provide services to facilitate the Agency’s consumer protection activities via litigation work and counseling advice. In particular, the Office of Chief Counsel will use the additional $300,000 and 2 FTE to:

Provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations; and,
Provide litigation support for enforcement, defensive and third party matters.

Food Safety + $100,000 and 1 FTE

FDA is currently focusing its food safety efforts to expand the scope of the highly successful multi agency Food Safety Initiative beyond just microbiological contamination of foods to include chemical and physical hazards as well. The increased funding of $100,000 and 1 FTE will provide the Office of Chief Counsel additional resources to:

Provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations; and
Provide litigation support for enforcement, defensive and third party matters.

Imports and Inspections + $300,000 and 2 FTE

FDA uses its inspectional authority, as directed by statute, to ensure the safety of products produced and distributed by more than 100,000 domestic establishments. FDA is also responsible for ensuring the safety of almost 7 million import line entries that cross the U.S. border annually. The offices under Other Activities provide Agency-wide support to FDA’s program centers on the postmarketing side. With the requested resources for OCC of $300,000 and 2 FTE, will:

Provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations; and
Provide litigation support for enforcement, defensive and third party matters.

Management Priorities + $8,300,000 and 3 FTE

This past year, the DHHS Inspector General performed a management review of FDA's existing financial system during the annual Chief Financial Officers (CFO) Audit, under OMB Circular A-127. OMB A-127 guidelines establish general requirements for Federal financial management systems and require an assessment to determine the degree of compliance or conformance with established system requirements. The review found several shortcomings in FDA's system, some of which can only be corrected by an investment in a new financial system. In addition, the expertise needed to maintain this large and complicated system is limited to a few individuals with knowledge of COBOL programming. The FDA Financial System supports all of the Agency's financial activities providing excellent information and internal controls and is considered a mission critical system needed to support FDA's public health mission. The FY 2002 request is for $8,300,000 and 3 FTE to:

Begin initial acquisition and implementation of the new financial system. Funding to complete the project will be requested in subsequent fiscal years.
Purchase off-the-shelf fully integrated financial system, which is less costly than developing in-house applications. Software upgrades are affordable and are regularly available. In addition, FDA is working to minimize other costs by taking advantage of work already performed by other DHHS agencies that are similar to FDA in size, scope, and transaction volume. FDA is coordinating with the Centers for Disease Control (CDC) in their procurement and implementation for a new financial system.

Current Law User Fees +$1,988,000
Prescription Drug User Fee Act (PDUFA) + $1,983,000

The Food and Drug Administration Modernization Act of 1997 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products through FY 2002 and established fees for applications, establishments, and approved products. The FY 2001 President’s Budget requested $149,273,000 and 920 FTE for PDUFA in FY 2001. In FY 2002, based on the information currently available and the statutory PDUFA formulas, an increase of 20 FTE and $12,443,000 over the FY 2001 current estimate, for a total level of $161,716,000 and 1,102 FTE is expected. Included in the FY 2002 total budget request for PDUFA, is $1,983,000 for the Other Activities program.

Mammography Quality Standards Act + $5,000

The Mammography Quality Standards Act of 1992 was reauthorized in 1998 for an additional five years (P.L. 105-298). The Mammography Quality Standards Act (MQSA) required that mammography facilities be certified by October 1, 1994, to remain in operation and inspected annually to ensure compliance with national quality and safety standards. FDA requests an increase of $5,000 for Other Activities in MQSA authorized inspection user fees to cover inflation, for a total of $186,000 and 2 FTE in FY 2002. The fees collected will pay for the costs of inspections.

JUSTIFICATION OF BASE

Payroll

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.

The Office of the Commissioner (OC): Provides leadership and expertise to manage the Agency including advice and assistance on legal and science issues, equal employment opportunity and civil rights activities which impact on policy development and execution of program goals.

Advise the Commissioner and other key Agency officials on scientific issues that have an impact on Agency policy, direction and long-range goals, and ensures coordination and communication throughout the Agency. Provides leadership in science management areas such as peer review of Agency science programs, recruitment and retention for key scientific positions, scientific resource management, and joint FDA/industry training on new technology. Advises on specific scientific issues such as dioxin in meat and milk, mercury in food, antibiotic resistance, safety of dietary supplements, safety of bioengineered foods, coordination of activities in clinical trials, human subject protection, and bioterrorism preparedness.
Provide a full range of legal services and advice, including responses to and/or review of the Department's Office of the General Counsel controlled actions, press/talking papers, legislative requests, congressional requests, materials for congressional hearings, Federal Register documents, disposition of FOIA requests, and legal support to FDA enforcement activities, including injunctions, seizures, subpoenas, and defensive litigations.

The Office of Policy, Planning and Legislation (OPPL): Provides advice and assistance in Agency policy development and oversees Agency rulemaking. It is the focal point for overall legislative liaison activities and advises and assists Congress on Agency actions, policies and issues. The office develops program and planning strategies and conducts operations research and economic and special studies as a basis for forecasting trends, needs and major problems. The office works to identify emerging issues and establishes forums for dialogue among FDA leaders to shape new strategies, while ensuring that internal and external stakeholders clearly understand FDA's challenges, achievements and future directions.

The Office of International and Constituent Relations (OICR): Coordinates responsibilities for women's health issues, special health issues, consumer affairs functions and international program issues that include the coordination of the international conference on harmonization and World Health Organization functions. OICR has expanded outreach into patient advocate communities, primarily in AIDS and cancer areas and has also served as a catalyst for scientific research to further Agency needs in product review and women's health.

The Office of the Senior Associate Commissioner (OSAC): Advises the Commissioner, Deputy Commissioners, Senior Associate Commissioners, and other key Agency officials on Agency-level activities and issues that affect Agency-wide programs, projects, and strategies. Coordinates activities involving emergency or crisis situations, and resolves complex problems and issues related to Agency programs that are sensitive and controversial which impact upon Agency relations with other federal agencies and foreign governments. Oversees and directs the Agency's ombudsman, public affairs, orphan products, executive secretariat, and advisory committee functions to ensure coherence in decision making and the efficient operation of these functions internally and across Agency jurisdictions.

Office of Management and Systems : Facilitates the effective and efficient management of people, money, tangible items, and systems for FDA.

Provides human resource and management services to approximately 9,000 headquarters and field employees across the country.
Manages FDA’s $1.3 billion budget, including Agency-wide budget formulation and execution, accounting, payment processing, financial reporting, foreign and domestic travel, employee relocation, payroll liaison and financial systems for two direct appropriations and four separate and unique user fee activities.
Provides nationwide logistical support for real and personal property, purchasing, grants, physical security, engineering services, environmental, safety, health and long range planning for FDA's future facilities.
Oversee building and maintaining an information technology infrastructure, and ensuring interoperability of FDA systems and support of a wide-area network.

Selected FY 2000 Accomplishments

The Office of the Commissioner:

Office of Science Coordination and Communication (OSCC)
Anti-Bioterrorism Preparedness. OSCC has been designated the FDA’s focal point for anti-terrorism preparedness activities. Responsibilities include providing overall coordination of anti-terrorism preparedness and response activities within the FDA and coordination of both internal and external communication on these issues. The Agency has created an Anti-Bioterrorism Preparedness Steering Committee. Ongoing activities include:

Coordinated with industry and outside organizations to review and resolve issues related to preparedness and response activities, such as the regulatory issues related to development and deployment of the National Pharmaceutical Stockpile, and the deployment of in vitro diagnostic devices for the detection of biologic agents in the National Laboratory Response Network;
Developed an FDA anti-bioterrorism preparedness strategic plan; and,
Enhanced communication between the FDA Centers through the Steering Committee.

Antimicrobial Resistance. The FDA Task Force on Antimicrobial Resistance developed an Action Plan and Recommendations that provides a list of priorities for the FDA as it moves forward in addressing the problem of antimicrobial resistance, a critical public health issue. To put these recommendations into action, the Office of the Commissioner has established an Implementation Committee whose mission is to provide overall coordination of the Centers’ implementation of the action items in the plan. The Action Plan and Recommendations have been posted on the FDA Website.

Human Subject Protection. In response to problems encountered in clinical research, FDA strengthened its programs for human subject protection during FY 2000. An Office of Clinical Science position was created, elevating FDA’s policy-making on human subject protection into the Office of the Commissioner and enhancing the coordination of human subject protection activities. Together with this new office, a Human Subject Protection Steering Committee was developed, bringing together senior policy-makers from across the FDA’s Centers and Offices. The Office of Clinical Science has spearheaded the close coordination of FDA’s human subject activities and activities with those of the new DHHS Office of Human Research Protection (OHRP), activities of FDA’s sister agencies, and extra-governmental stakeholders.

Office of Chief Counsel (OCC)
OCC provided leadership and direction in the effective use of enforcement actions, such as cases involving Wyeth, American Red Cross, and Abbott, to achieve FDA compliance objectives. Provided legal review and clearance of regulations to achieve significant public health objectives, including physician labeling, juice HACCP, biotech premarket notification, structure/function claims, blood safety, xenotransplantation, and gene therapy disclosure. Coordinated with the Department of Justice the legal strategy and approach to effectively defend significant litigation challenging FDA program objectives, including Cholestin (dietary supplements), American Bioscience and Watson (generic drug approvals), and ABI (food biotech policy).

The Office of International and Constituent Relations:
Office of Women's Health (OWH)
Science Program. OWH's scientific research program addresses gaps in current knowledge, encourages new directions, and sets new standards of excellence in women's health. The program consists of four distinct components:

Special Funding Activities - This program provides funding for regulatory projects which require the Agency's immediate attention. This includes workshops, conferences, small scientific research projects, focus group testing and publications. As an example, focus groups determine if young women were using tampons safely. The focus groups showed that young women read tampon labels, use tampons properly, but tend to overestimate the risk of Toxic Shock Syndrome.
Women's Health Program - National Center for Toxicological Research - This pilot program was developed as a five-year research program aimed at applying the developing techniques of genomics and protenomics to address gender differences in the safety of medical products. FY 2000 projects focused on addressing gender differences in the safety of medical products and dietary supplement/drug interactions.
Centers of Excellence in Women's Health - The National Centers of Excellence in Women's Health (CoEs) serve as demonstration models for the Nation to provide innovative, comprehensive, multidisciplinary, and integrated health care systems for women. OWH funded six contracts for research projects at these Centers to determine dietary supplement use in women and to investigate dietary supplement/drug interactions. These extramural projects at academic medical institutions are ongoing.

Mammography.The FDA/OWH sent a letter to all 10,000 certified mammography facilities inviting them to showcase the availability of our "Mammography Today" brochure and distribute a one-page abbreviated version of the brochure to inform patients about their new rights.

Health Promotion. OWH and Public Affairs Specialists provided a range of women's health educational materials to consumers at approximately 75 national conferences. In support of these efforts, one million copies of our various publications were distribution to the public. A range of topics were presented including heart disease, breast and cervical cancer, osteoporosis, diabetes, arthritis, clinical trails, and depression.

The Office of Policy, Planning & Legislation:

Office of Planning
Mandated under the Government Performance and Results Act (GPRA), the FY 2002 Annual Performance Plan and Summary was redesigned so that it focuses on key strategies in language that is easily understandable to lay people. This format also allows Agency managers to use the results of complying with the GPRA. Each strategy highlighted FDA's Key Performance Goals; explained FDA's contribution; outlined its proposed actions; identified barriers to achieving the goal and the consequences of not achieving the goal, as well as an assessment of the present status of the strategy.

Coordinated Leadership activities that developed budget strategies for FY 2002. These strategies involved four, cross-agency teams that identified opportunities to work with other organizations, benefits of successfully implementing the strategy and allocation of resources to each strategy.

Office of Evaluation
Produced and provided the FY 1999 PDUFA Performance Report to Congress. The PDUFA of 1992 requires that an annual report on the Agency's performance under PDUFA be sent to Congress. The FY 1999 report showed detailed statistics on the Agency's performance against the progressively more stringent review performance goals and against a new set of goals designed to make the Agency more responsive to sponsors and to speed up the early stages of drug development.

Office of Policy
Pediatric Exclusivity. In 1997, as part of the FDAMA, Congress enacted a provision which provides six months of exclusive marketing to drug manufacturers in return for conducting needed pediatric studies. The "pediatric exclusivity provision" has been highly effective in generating pediatric studies on many drugs and in providing useful new information in product labeling. By the end of FY 2000, FDA had issued over 150 requests to manufacturers to conduct over 300 pediatric studies. Almost 60 pediatric studies had already been conducted. As a result of the pediatric exclusivity provision, critical drugs used to treat a variety of conditions, e.g., gastroeophageal reflux disease, diabetes mellitus, pain, asthma, and hypertension, have or soon will have pediatric use information in their labeling.

The Office of Senior Associate Commissioner :
Office of Public Affairs

Received, coordinated, and monitored processing of 25,011 FOIA requests.
Managed FDA’s denials and appeals process and issued 245 denials of FOIA requests.
Posted approximately 1300 warning letters on the Electronic FOIA Reading Room Internet web page.
Distributed 1,440,000 Agency consumer publications through GSA’s Consumer Information Center, Pueblo CO.
Published six issues of FDA Consumer, which won second place in the periodicals category in the Blue Pencil nationwide competition of the National Association of Government Communicators.

Office of Executive Secretariat
Plain Language at FDA. In FY 2000, FDA won two “No Gobbledygook” Plain Language Awards, bringing the total to four – more than any other Federal agency. FDA has always used plain, clear language in consumer publications. FDA continues to work to encourage the use of plain language tools and techniques in all regulations and guidance documents, reports to Congress, and budget documents.

The Office of Management and Systems:

Office of Financial Management

Received an “unqualified opinion” from independent auditors on the FDA FY 1999 financial statements under the CFO; received, for the second year in a row, the Department’s CFO Award in recognitition of the audit results.
Awarded a contract to Arthur Andersen to assist in development of a business plan for the replacement of the current financial system to improve and expand customer services.
Participated in the formulation of a Financial System Workgroup, at the Department level. The efforts of the workgroup will reduce out year costs for the business case development by overseeing the contractor in analyzing the system requirements across the OPDIVS and documenting several viable business solutions.

Office of Information Resources Management
Computer Security (Critical Infrastructure Protection (CIP)). FDA's increasing reliance on computer-generated information meant greater focus on efforts to ensure this information and its supporting technological infrastructure remains secure. To that end, FDA accomplished the following in FY 2000:

Completed physical and system security audits to evaluate access controls to ensure FDA's information is not compromised by internal or external threats; audit revealed that controls are adequate; periodic review of controls are being implemented; and,
Provided leadership and focus to complete the Agency’s Y2K remediation program for facilities, biomedical equipment, telecommunications, and outreach activities; and established the Agency’s Y2K Day One program for final verification and validation of Y2K compliance. Also, coordinated a successful FDA-wide Y2K transition.

FDA Internet/Intranet Services and Support. The FDA public website provides critical health information to the public and offers information of interest to health professionals, patients, consumers, industry, State, and local officials and many others. The Internet web infrastructure has supported FDA by providing rich functionality, responding to changing needs, and by providing high performance and reliability. In FY 2000, FDA significantly expanded the FDA Internet website infrastructure and services provided to FDA developers and the public.

Received numerous awards for the FDA website from Popular Science magazine, the Dow Jones Business Directory, and Tufts University’s Nutrition Navigator. The Website links to 8,000 health, consumer, medical, and educational websites, and the site received an average of 1,321,236 hits per day. This website provides information such as status of FDA proposed and final regulations, letters to the public, import alerts, stakeholder meetings, and guidance for good manufacturing and agricultural practices.

Office of Facilities, Acquisitions and Central Services

Hosted a Women-Owned and Small Business (WOSB) Seminar and Expo for WOSB vendors to display materials and discuss their capabilities for future FDA requirements. The Expo was designed to increase opportunities for women-owned small businesses.
Provided engineering and contractual management and support for: the following major FDA facilities projects:
Headquarters Consolidation in Prince George’s County, Maryland--The General Services Administration (GSA) is constructing a 410,000 gross square foot building to consolidate the Center for Food Safety and Applied Nutrition (CFSAN) in College Park, Prince George's County, Maryland. This consolidation project has been authorized through the FDA Revitalization Act of 1990. The College Park building is scheduled to be complete in October 2001. CFSAN will move into the new building between October 2001 and February 2002. Based on the value of work in place, the construction is 75 percent complete and remains on schedule for completion by October 1, 2001.
Headquarters Consolidation in Montgomery County Maryland. The GSA has developed a master plan for a 2.2 million gross square foot development to consolidate the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics and Research (CBER), headquarters components of the Office of Regulatory Affairs and the Office of the Commissioner. This consolidation project has been authorized through the FDA Revitalization Act of 1990. Groundbreaking for the first phase of the project occurred in October 2000 and will result in construction of an 114,000 gross square foot laboratory building for CDER. Design is underway for the second phase of the project that includes all the office space needed to fully consolidate CDER.
Field Laboratory Consolidation in Irvine California. The new Los Angeles field laboratory project in Irvine, California is designed as a 120,000 gross square foot facility that will be occupied by three Los Angeles District components. Not only will this facility provide a safer location and improved working environment, but also by concentrating the scientific talent and resources to one location it will permit better management of the analytical workload and will provide significant improvement in operational efficiency. FDA purchased a 10-acre land parcel located in Irvine, California. Design of the facility is complete. A groundbreaking ceremony was held on March 6, 2001.

Office of Human Resources and Management Services

Coordinated the first Agency-wide workforce-planning program, designed to engage FDA leadership in a systematic process for anticipating future workforce requirements and planning ways to fill the gaps between existing resources and future requirements.
Initiated new Internet processes of accepting comments electronically and allowing the public to electronically register for public meetings, which helped the public keep up with and respond to FDA’s regulatory programs. Many enhancements to FDA’s Dockets Website improved access to FDA data and expanded the amount of material available on the Internet. Starting in January 2000, FDA began posting Advisory Committee Briefing packages on the Web, as required by a stipulation in a court case. During FY 2000, customers downloaded more than three million files directly from the Dockets web site.
Facilitated the Hispanic Recruitment Retention and Advancement (HRRA) Work Group, which included the production of an action plan and report for the Commissioner. As a result, the Commissioner established a Senior Advisory Board on Hispanic issues charged with making decisions on the implementation of action plan recommendations.

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