STRATEGIC GOAL AREA: POSTMARKET ASSURANCE

FY 1999 Performance Goal Highlights Contract with all 50 states to conduct monthly unannounced compliance checks of retail establishments that sell tobacco. Conduct meetings and a multimedia outreach campaign to educate retailers and other stakeholders about their obligations under the FDA tobacco rules and assist retailers in meeting their new responsibilities. Design and implement a regulatory program for cigarettes and smokeless tobacco products.

Cluster Rationale: Reducing the use of tobacco by young people is an enormous undertaking with potential for great public health outcomes. Given the early stage of implementation of FDA's regulation of tobacco products and the court challenges to FDA's jurisdiction and rule, a single cluster is appropriate.

On August 23, 1996, President Clinton approved FDA's final rule, regulating nicotine-containing tobacco products. The final rule would limit the availability and appeal of tobacco products to younger people. It would limit the access that young people have to tobacco products by setting a minimum age of purchase, requiring that retailers check a photo identification of all customers under the age of 27 when purchasing tobacco, banning self-service and vending machine sales, and banning free samples. The final rule would also limit the appeal these products have for young people by imposing stringent advertising restrictions on most advertising media. Some of these restrictions include banning billboards within 1000 feet of schools and playgrounds, banning all non-tobacco items identified with a tobacco brand, and sponsorship of events by tobacco companies.

The United States District Court for the Middle District of North Carolina (Greensboro Division) upheld the Agency's assertion of jurisdiction over cigarettes and smokeless tobacco products, but delayed implementation of all provisions, pending appeal, except those already in effect for age and ID. The case is currently on appeal in the United States Court of Appeals for the Fourth Circuit.

Resources, Approaches, Processes, Skills, and Technology: Resources are primarily devoted to inspecting retail facilities and prosecuting those establishments repeatedly found to violate the age and ID restrictions. Resources will also be used to conduct outreach and education programs for retailers and other stakeholders about their responsibilities under the rule, and to coordinate efforts with state and local public health agencies and voluntary health organizations. In addition, resources will be used to develop and implement a regulatory program.

FDA's rule requires that retailers not sell tobacco products to anyone younger than 18 and that they check a photo identification for anyone younger than 27. FDA will enforce this restriction by commissioning state and local health officials to conduct unannounced purchase attempts using young people under the age of 18. Retailers who do not sell tobacco products to the minor will receive a letter informing them that they are in compliance with the rule. Those who do sell to the minor will receive a letter informing them that they have violated the rule, and that another inspection may occur in the near future. If on the second purchase attempt, the retailer sells to the minor, the Agency will seek to impose a $250 civil money penalty. Penalties for subsequent violations rise to $10,000.

FDA will create a database of all retailers who sell tobacco and assign retailers to be inspected and reinspected to each commissioned state. The reports of the inspection will be faxed to FDA who will mail a letter to the retailer and a copy to the state. The database will also be augmented by reports of suspected retailer violations made by citizens using FDA's toll free hotline and FDA's website.

FDA will also work with retailer organizations and other stakeholder organizations to inform them of their responsibility under the rule and to assist them in complying with the rule. Regional meetings and teleconferences will be held as new provisions of the rule come into effect. Materials will also be available on FDA's website and via FDA's toll free hotline. Finally additional materials will be developed as new issues of compliance arise.

FDA will work closely and cooperatively with the Centers for Disease Control and Prevention's (CDC's) Office on Smoking and Health and the Substance Abuse and Mental Health Services Administration (SAMHSA) to conduct surveys to measure compliance with the rule, to monitor buy rates, and to measure success in reducing initiation and use of tobacco by young people. These surveys will be primarily of two types: 1) a national survey of young people to determine among other things, initiation, prevalence, buy rates, and actual or attempted buys; and 2) a national field inspection survey in which a random sample of different types of retail establishments are surveyed for illegal sales. The findings of these surveys would be widely reported and used to determine whether additional measures are needed, and to motivate directed efforts to address documented high-violation-rate segments of the tobacco-distribution system.

The CDC IMPACT program and NCI ASSIST program both involve tobacco control activities at the state and local levels. The state officials participating in the IMPACT and ASSIST programs are potential partners for the implementation of FDA's final rule. This increased effort in the arenas of outreach and enforcement activities, coupled with coordinated efforts by CDC, SAMHSA and other components in the Department of Health and Human Services (DHHS), will enhance the DHHS's ability to meet its long-term goal of reducing young people's use of tobacco by 50 percent over 7 years.

Finally, in FY 1999, FDA will design and, to the fullest extent permitted under any court orders addressing such activities, begin to implement a regulatory program for cigarettes and smokeless tobacco products under the Food, Drug, and Cosmetic Act, including:

1. The beginning of the classification of the product pursuant to Section 513 of the Act;

2. The beginning of the inspection process by reviewing the practices of tobacco companies and the provision of assistance to the industry in coming into compliance with the requirements of the quality system regulations pursuant to 21 CFR, Part 820;

3. The beginning of the appropriate review and analysis of the ingredients and constituents; and

4. Establishment of an evaluation and review procedure for new products.

Strategic Goal Area:	POSTMARKET ASSURANCE
Cluster:	Tobacco
1. Enter into contracts with all 50 states (depending on their willingness) to conduct an average of 42,000 unannounced compliance checks each month of retail establishments that sell tobacco products. [1]
Agency Strategies:	Maintain inspection visibility. Collaborate with federal and state regulators to reduce health risk. Use third-parties for routine compliance monitoring.
Data Sources:	Completed contracts with states.
Baseline Data:	Under development. [2]
2. Conduct meetings and a multimedia campaign, including point-of-purchase, radio, outdoor advertising, and newspapers, to educate retailers and other stakeholders about their obligations under the FDA tobacco rules and the impact of the rules. Distribute at least 100,000 brochures and fact sheets to retailers on request.
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	Internal FDA records.
Baseline Data:	Under development. [2]
3. Design and, to the fullest extent permitted under any court orders addressing such activities, begin to implement a regulatory program for cigarettes and smokeless tobacco products, including: The beginning of the classification of the product pursuant to Section 513 of the Act. The beginning of the inspection process by reviewing the practices of tobacco companies and the provision of assistance to the industry in coming into compliance with the requirements of the quality system regulations pursuant to 21 CFR, Part 820. The beginning of the appropriate review and analysis of the ingredients and constituents, and Establishment of an evaluation and review procedure for new products.
Agency Strategies:	Develop science-based product and process standards.
Data Sources:	Internal FDA records and industry submissions.
Baseline Data:	Under development. [2]

1. Achievement of goal assumes that additional personnel can be acquired via contract or other means.

2. Note about performance baselines: Performance baselines will be developed using existing internal tracking data and a newly developed computer tracking system. Data from surveys conducted by the CDC's Office on Smoking and Health and from the Monitoring the Future Project (funded by a grant from the National Institute On Drug Abuse (NIDA)), once the program is fully implemented, will be used to measure rates of initiation and tobacco use by young people. In addition, the DHHS Data Council, which coordinates all health and non-health data collection and analysis activities of DHHS, asked DHHS agencies (e.g., FDA, SAMHSA, and CDC) to review the data requirements which could arise from the potential legislative settlement with the industry. Based upon this charge, a DHHS-wide workgroup was formed to review the data requirements for: youth surveillance; environmental tobacco smoke (ETS) exposure; monitoring social and policy factors; and tobacco product and smoke constituents surveillance. The workgroup will provide the Secretary with recommendations regarding the data needs and appropriate methods for all five areas, including designing surveys to measure baseline and performance goals. These surveys will provide FDA with the appropriate measurement devices for its performance goals

STRATEGIC GOAL AREA: POSTMARKET ASSURANCE

FY 1999 Performance Goal Highlights Accept 20% of imports into the U.S. market through evidence of equivalent source-country quality systems, standards or audits. Enhance screening capabilities while ensuring that 55% of entries are released within 15 minutes. Assess potentially violative imports through direct examination of 3% of entries.

Cluster Rationale: FDA is responsible for assuring that 50 billion dollars in annual food, drug and devices imports meet regulatory requirements necessary for marketing and consumption within the United States. FDA operates in a dynamic environment characterized by: rapid growth in the volume of import shipments (from 1.5 million in 1990 to more than 3 million in 1997); increasingly complex products; diversity in the technological competence of sources; emerging pathogens and novel public health risks; changing global trade patterns; and evolving approaches to international regulation.

Resources, Approaches, Processes, Skills and Technology: FDA, working independently, would find it very difficult to address these regulatory challenges. FDA inspectors, for example, can physically examine only a small percentage of import entries. Consequently, the Agency has undertaken a combination of strategies which will provide a rigorous, comprehensive assurance of import quality. These strategies are directed toward: enhancing measures within source countries to reduce the likelihood of shipment of violative products to the U.S.; rapidly screening documentation of all entries to identify probable violative products; and promptly assessing potentially violative products at their point of entry.

Preventive Measures Applied At the Source of Production (Goal 1) FDA relies on strategies that increase its confidence in the safety and efficacy of imports at their source of production. This assurance is obtained in a variety of ways. U.S. consumer interests are protected in the process of negotiating bilateral and multinational agreements on specified products and in forums that result in development of acceptable international product standards. These standards may be extended to a larger percentage of imports through the use of third-party certifications, and via agreements that source countries confirm product conformance to these standards. Preventive measures are also achieved through inspection of foreign manufacturers by FDA, primarily for drug and medical device products.

Rapid Access To Safe Products (Goal 2) FDA is relying on an electronic screening system as a key strategy in managing the growing volume and complexity of imports that are entering the U.S. from a widening variety of sources. This system, the Operational and Administrative System for Import Support (OASIS), allows for quick review of entries, based on mutual agreements with source countries, experience from product violation patterns, and products with a high-risk potential. Electronic access to this history enables FDA to separate products that can be rapidly cleared for entry from those that require physical examination and /or laboratory analysis. OASIS will become an increasingly "smart" system as more comprehensive background information can be accessed, leading to a higher percentage of import entries for which prompt, comprehensive risk assessment decisions can be made. FDA is leveraging its resources in this strategy through partnership with the U.S. Customs Service for both the management of the system and in the development of additional information to facilitate enhanced regulatory decision-making.

FY 1999 will be the first year for which a full year of OASIS operation experience and data will be available to Agency managers to assess the use of and need for resources. The automation of easy product entry decisions for foods has nearly been exhausted. Additional progress in automating entry decisions for either the drug or device programs will depend on the ability to devote resources to build the infrastructure needed to link their data systems into OASIS so that more information can be available on line.

Preventing Violative Products From Entry (Goal 3) FDA must continue to devote a substantial proportion of its import resources to maintain a highly responsive capability for monitoring potentially violative imports. In the past, this vigilance has focused on the containment of such import risks as chemical contaminants in the food supply, pesticide residues in fruits and vegetables, and lead in ceramic dinnerware. Dramatic increases in global trade make FDA's job more challenging than ever because product components and adulterants are available that do not yet conform to FDA's standards. To the extent that preventive measures within source countries prove effective, such risks can be decreased via means that require less direct analysis by FDA officials. However, the FY 1999 environment necessitates that FDA maintain a continuing level of import sampling and examinations to respond to evolving and unexpected import risks.

Strategic Goal Area:	POSTMARKET ASSURANCE
Cluster:	Imports
1. Accept at least 20% of imports into the U.S. market through evidence of equivalent source country quality systems/standards/audits.
Agency Strategies:	Integrate import and international harmonization activities.
Data Sources:	Internal management data and U.S. Department of Commerce trade statistics.
Baseline Data:	The international trade data used to evaluate the status of this goal are affected by the nature and timing of evolving international agreements and standards. These data will be used to determine the volume of imports that conform with FDA requirements under these agreements and standards.
2. Enhance import screening capabilities for public health while ensuring that 55% of entries are released within 15 minutes.
Agency Strategies:	Develop science-based product and process standards.
Data Sources:	OASIS records.
Baseline Data:	FY 1997: approx. 50%
3. Assess potentially violative imports through direct examination of 3% of entries.
Agency Strategies:	Maintain inspection visibility.
Data Sources:	Field Information System.
Baseline Data:	FY 1997: approx. 2%.
	FY 1996: 3.3%.

STRATEGIC GOAL AREA: EXTERNAL LEVERAGE

FY 1999 Performance Goal Highlights Establish regulatory partnerships with every state. Conduct 75 industry workshops that result in increased compliance and consumer protection. Correct a majority of problems noted in manufacturing or processing operations via cooperative action.

Cluster Rationale: An effective way that FDA can meet its challenge of assuring the safety of regulated products in the marketplace is by developing ways to utilize partners in mutually advantageous endeavors.

Resources, Approaches, Processes, Skills, and Technology: Through regional and district offices and program centers, ORA will increase the number of Federal-state partnerships that are built on the abilities of partners. Partnership Agreements focus on program responsibilities in such areas as inspections, sample collection, sample analysis, and joint development of shared databases.

In industry workshops, there is exchange of technical and scientific knowledge and information on laws and regulations between FDA and industry professionals. FDA conducts industry workshops on a variety of regulated products in order to increase compliance and consumer protection.

Cooperative actions with industry to obtain compliance are an efficient, effective tool for FDA. The Agency uses the Compliance Achievement Reporting System (CARS) to capture industry compliance to FDA requirements when it occurs prior to a legal action. Activities to accomplish compliance include inspections, meetings held with industry, sending notification of analytical results, issuance of Warning Letters, or import detentions. The Agency plans to coordinate the data in the CARS system with that of the Field Accomplishment and Compliance Tracking System (FACTS). FACTS is a new, more flexible and comprehensive Field data system for which implementation begins in FY 1998. This combination of compliance achievement information will better enable the Agency to evaluate its progress toward achieving its strategic goal of postmarket assurance.

Strategic Goal Area:	EXTERNAL LEVERAGE
Cluster:	External Leverage
1. Expand the system of State Partnership Agreements to comprise at least one per state to increase both quality and efficiency between the Federal, state, and local officials.
Agency Strategies:	Collaborate with Federal and state regulators to reduce health risks.
Data Sources:	Office of Regulatory Affairs State-Federal Partnership Agreement Data Base.
Baseline Data:	FY 1997: 104 Partnerships established in 43 states.
2. Publicize and conduct 75 workshops for regulated industry coordinated and/or sponsored by the FDA field offices focusing on providing Agency-wide product line training that results in increased compliance and consumer protection.
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	Office of Regulatory Affairs - Field Information.
Baseline Data:	FY 1998: Baseline being established.
3. Correct a majority of significant problems identified in manufacturing/processing operations via prompt, cooperative action.
Agency Strategies:	Inform and assist firms to achieve conformance.
Data Sources:	This performance goal is intended to reflect a major strategic shift that has occurred in FDA's field operations, from traditional "command and control" regulation toward a collaborative, problem-solving focus. In 1996, FDA initiated a data collection system, the Compliance Achievement Reporting System (CARS), to collect information on instances in which FDA officials obtained compliance through voluntary actions by firms as a result of regularly scheduled inspections, meetings with firms, notification of analysis or import detentions. The data system that captures these successes, CARS, will be coordinated with the new Field Accomplishment and Compliance Tracking System (FACTS) during FY 1999 so that a comprehensive baseline of information on problem types, categories of intervention and problem solutions can be established. This combination of compliance achievement information will enable the Agency to evaluate its progress toward achieving its strategic goal of postmarket assurance through cooperative action.