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A. Regarding FDA's Good Guidance Practices, published February 27, 1997, FDA already has taken a number of steps to ensure that agency employees involved in the development, issuance, and application of guidance documents understand that guidance documents are not legally binding. First, all guidance documents include a statement that describes the nonbinding nature of guidance. Second, the centers and offices responsible for developing, issuing and applying guidance documents have held training sessions, which emphasized the legal effect of guidance documents. Finally, the agency is continuing to monitor its employees' use of guidance documents to ensure that they are not being applied as binding requirements.
A. The goal of FDA's tobacco rule is to reduce the number of children who smoke or chew tobacco. The rule is designed to limit the availability and appeal of tobacco products to young people. The Agency has created a Web page that explains the details of our work on tobacco at www.fda.gov. Once on the FDA home page, simply click on the "Children and Tobacco" symbol. The other part of your question appears to raise the hazards of second-hand cigarette smoke to the unborn, newborn and children. This issue is within the authority of the Environmental Protection Agency."
A. The Office of Criminal Investigations (OCI) was established in 1992 to provide the FDA with a specific office to conduct and coordinate all criminal investigations related to the Federal Food Drug and Cosmetic Act (FFDCA) and other related acts. OCI special agents employ customary federal law enforcement methods and techniques in the investigation of suspected criminal violations of the FFDCA, the Federal Anti-Tampering Act (FATA), and other related federal statutes. OCI concentrates its resources on significant violations of these laws, with priority on conduct that may pose a danger to the public health. Enforcement of the FFDCA will contribute to the enhancement of the agency's scientific decision making by encouraging the timely submission of complete and accurate data.
A. When Congress held confirmation hearings for Dr. Jane Henney, Commissioner, last Fall, she committed to creating a new organizational structure for the Commissioner's Office that would fit her management style. To help Dr. Henney create a new vision for the Commissioner's Office, Linda A. Suydam, Senior Associate Commissioner chaired a task group that gave priority attention to studying and ultimately redesigning OC into a somewhat different organization with fewer people. As Dr. Henney announced on April 22 to all FDA employees, "The principal focus of the office is to provide leadership in building effective, two-way communication between the Agency and all of our stakeholders, including patients, consumers, Congress, the Administration, Agency employees, the regulated industry, health care professionals, and other scientific advisors." The new structure is more streamlined and flatter. The reorganization specifically moves some functions now residing in the Office of the Commissioner to the Centers or ORA. As a result, a number of offices were realigned, approximately one hundred individuals have been redirected to the programmatic centers, and a limited number of positions abolished. A final plan should be approved by our employees union soon and have the major changes in place this summer.
FDA is considering a variety of media and information technologies to communicate with stakeholders. Last year, we sought input from stakeholders at meetings in Washington and of course, through the Federal Register and submission of comments to the FDA Docket. This past April, we used live, interactive satellite teleconference, regional meetings, and Webcasting, in addition to the Federal Register, as the primary vehicles for communicating and collaborating with our stakeholders. Next year, we will consider using cable television as an approach to communicating with "the ultimate stakeholder" in their homes.