Center jurisdiction

Independent of these centers, the FDA also has overlapping jurisdiction with several other federal agencies, including the U.S. Department of Agriculture the Bureau of Alcohol, Tobacco, and Firearms the Federal Trade Commission and the Environmental Protection Agency. 

Suspension of licensing authority for medical personnel from outside jurisdictions Authorization of other doctors to perform functions of medical examiner Access to Communications and Parking Relations Identification of public health officers, e.g., badges Dissemination of accurate information, rumor control, 1-800 numbers Establishment of command center Access to elected officials... 

Recent years have seen a vast increase in the number of new therapeutic products which are not purely drug, device, or biologic, but rather a combination of two or more of these. This leads to a problem of deciding which of the three centers shall have ultimate jurisdiction. 

For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the centers. 

At the FDA, the Center for Drug Evaluation and Research (CDER) is responsible for the approval of small molecule drugs and therapeutic biologies while nontherapeutic biologies and blood products are under the jurisdiction of the Center for Biologies Evaluation and Research (CBER). 

For regulatory purposes, a combination product is assigned to an agency center or alternative organizational component that will have primary jurisdiction for its premarket review and regulation. Manufacturers will be required to use the applicable GMP for their products. Regulations that may apply are ... 

In Part V, we examine research and ethics. Increasingly, clinical research is undertaken in multi-center studies involving numerous countries and jurisdictions. Argentinian bioethicist Florencia Luna, a past president of the International Association of Bioethics, introduces one of the major issues debated in recent years in international research ethics in this context, namely the question of what constitutes appropriate standards of care for participating patients. The line taken by the U.S. National Institutes of Health and many American bioethicists has been that it is acceptable for developed world sponsors of such trials to provide less than the best proven therapeutic means of treatment to the trial participants. Developed world-based bioethicists do not always agree and Luna explains why. 

For example, the scaffold or biomaterial component of a neo-organ would normally fall under CDRH jurisdiction, while biological components (i.e., cells) would normally fall under CBER s authority if these components were being used alone. Similarly a biologically active pharmaceutical product would normally be reviewed by CDER. However, review of a combination product can require expertise from multiple centers and the lead center is assigned based on the component that the FDA decides is delivering the primary mode of action. 

The National Drug Intelligence Center s 2003 National Drug Threat Survey is a report that draws on information from nearly 2,900 state and local law enforcement agencies as well as from more than 1,000 personal interviews with law enforcement and public health officials. The survey shows that 5.7% of state and local law enforcement agencies nationwide identify Rohypnol availability as high or medium, while 47.4% indicate that availability is low. Another 42.8% of state and local law enforcement agencies nationwide report that Rohypnol is not available at all in their jurisdictions. 

Although a comprehensive survey of occupational and residential exposure data requirements across all regulatory jurisdictions is beyond the scope of this chapter, it is evident that the majority of jurisdictions require an assessment of exposure for conventional pesticides if the proposed use pattern indicates potential handler exposure (either occupational and residential) or agricultural re-entry exposure. The extent to which exposure assessments are required/conducted for residential re-entry scenarios or bystanders, however, is less uniform. Although most jurisdictions require/conduct assessments for residential re-entry scenarios (e.g. treated turf, carpeL etc.), exposure assessment methodology for other types of bystander exposure scenarios (e.g. residential exposure in agricultural areas, direct exposure to drift, exposures from the use of pesticides in schools, daycare centers and other public places) is less mature and requires further collaboration. 

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

HCF personnel, ES H Center personnel, and Facilities Operations and Engineering (FOE) Center personnel share responsibilities for initial startup testing at the HCF. For example, HCF personnel may functionally test tools and equipment intended for use in the steel confinement boxes (SCBs) using the mockup manipulator arm located in Room 101 before the tools and equipment are inserted into the SCBs. ES H Center personnel test the radiation-monitoring system. Facilities Operations and Engineering Center personnel are responsible for performing initial tests on all major modifications, and SSCs under their jurisdiction (e. g., fire-suppression system). 

In the Oro Bay location, the training center and school came under the jurisdiction of the Chemical Officer, Intermediate Section, USA-SOS. Intermediate Section (later New Guinea Base Section) was a forward area service and supply command with jurisdiction over all... 

National Center for Education Statistics. (2011). Digest of Educational Statistics, 2010. Table 36. Enrollment in public elementary and secondary schools, by state or jurisdiction Selected years, EaU 1990 through Fall 2010. Accessed March 14, 2012. http //nces. ed.gov/programs/digest/2010menu tables.asp. 

However, as these products typically consist of more than one component, such as biomolecules, cells, or tissues combined with a biomaterial, they are considered Combination Products and regulated under the jurisdiction of CBER, CDRH, or the FDA s third medical product review center, the Center for Drug Evaluation and Research (CDER). A determination of the product s primary mode of action dictates the jurisdictional authority for the product and the primary reviewing center other centers act as consultants in the review process. 

The Office of the Combination Products was established under the aegis of the Medical Device User Fee and Modernization Act of 2002. This office has responsibilities over the regulatory life cycle of combination products, and (1) assigns the FDA Center for primary review jurisdiction of the product (2) works with FDA Centers to develop regulatory guidance and clarify regulation of these products and (3) serves as a focal point for combination product-related issues for internal and external stakeholders. 

An agency of the federal government with responsibility for public health in its broadest aspects. This agency is under the jurisdiction of the U.S. Public Health Service (USPHS) and includes the following (1) Alcohol, Drug Abuse and Mental Health Administration (2) Center for Disease Control (CDC) (3) Food and Drug Administration (FDA) (4) Health Resources Administration (5) Health Services Administration and (6) National Institutes of Health (NIH). 

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