Federal Agencies Impact Radiology
Regulatory Affairs
ACR staff members actively monitor federal agency activity, responding to and influencing federal agency policies and regulations. The ACR routinely submits public comment and provides agency testimony on issues that affect the practice of our members. ACR also maintains ongoing relationships with agency staff, an important complement to our more formal interactions. Some of the key agencies that work with the ACR are listed below. For more information on current activities in the regulatory arena, check out the federal agency relations section of ACR's Web site at www.acr.org. Direct specific questions about ACR regulatory activities to Gloria Romanelli, senior director, Legislative and Regulatory Relations at gromanelli@acr.org.
Key Federal Agencies
Agency for Healthcare Research and Quality (AHRQ)
The AHRQ is the lead federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans. As one of 12 agencies within the Department of Health and Human Services, AHRQ offers grants for health services research that will improve the quality of health care and promote evidence-based decision making. Provider information ranges from clinical guidance to practice management considerations, such as health information technology, that impact the delivery of health services.
For more information, visit www.ahrq.gov.
Centers for Disease Control and Prevention (CDC)
The CDC seeks to accomplish its mission by working with partners throughout the nation and the world to monitor health, detect and investigate health problems, conduct research to enhance prevention, develop and advocate sound public health policies, and implement prevention strategies. In addition, ,CDC promotes healthy behaviors, fosters safe and healthful environments, and provides leadership and training. It also offers information on emergency (radiological disaster) preparedness, workplace safety and health issues, radiation safety, and cancer screening.
CDC is also the parent organization for the National Institute for Occupational Safety and Health (NIOSH). NIOSH is responsible for conducting research and making recommendations to prevent work-related injury and illness. Additionally, CDC oversees the B reader proficiency certification program for qualifying physicians to read chest radiographs for evidence of pneumoconiosis and related conditions.
For more information, visit www.cdc.gov.
Department of Energy(DOE)
The DOE's Office of Nuclear Energy produces and sells many stable and radioactive isotopes that are widely used by domestic and international customers for medicine, industry, and research.. DOE also maintains the infrastructure required to support the national need for a reliable supply of isotope products, services, and related technology.
The DOE's Office of Science nuclear medicine program has supported research into novel radiopharmaceuticals for medical research and studies of novel instrumentation for imaging of living systems for medical diagnosis. In the nuclear medicine program, universities have conducted research into new types of radiopharmaceuticals, particularly those based on application of concepts from genomics and structural biology.
The Office of Biological and Environmental Research (BER) emphasizes radiopharmaceuticals that will be of use in advanced imaging techniques such as positron emission tomography. The research has supported new instrumentation for medical imaging. The BER Measurement Science program has supported research into novel types of biosensors for medical imaging and application in analytical chemistry of contaminated environments.
For more information, visit www.energy.gov.
Department of Homeland Security (DHS)
The DHS was created to provide a unifying core for the vast national network of organizations and institutions involved in efforts to secure our nation from terrorist attacks. DHS goals include awareness of vulnerabilities, disaster prevention, protection of citizens, and disaster response and recovery. DHS would be a primary partner in the event of a radiological disaster.
For more information, visit www.dhs.gov.
Department of Labor; Occupational Safety & Health Administration (OSHA)
As a component of the Department of Labor, OSHA's mission is to assure the safety and health of America's workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace safety and health. OSHA and its state partners have about 2,100 inspectors and other staff spread over more than 200 offices throughout the country. OSHA staff establishes protective standards, enforces those standards, and reaches out to employers and employees through technical assistance and consultation programs. OSHA is currently considering updating its requirements related to ionizing radiation.
For more information, visit www.osha.gov.
Food and Drug Administration (FDA)
The FDA is charged with the promotion and protection of public health by helping safe and effective products — including devices and pharmaceutical products used in imaging — reach the market in a timely manner. It also oversees labeling the products it approves and monitors these products for continued safety after they are brought to market.
The FDA is also charged with regulating in other areas. For example, it is responsible for. implementing and overseeing the Mammography Quality Standards Act.. Moreover, the radiological health program of FDA's Center for Devices and Radiological Health (CDRH) is responsible for protecting the public from hazardous or unnecessary radiation emissions from electronic products. CDRH does this by addressing all types of radiation resulting from medical and nonmedical electronic products.
For more information, visit www.fda.gov.
National Institutes of Health (NIH)
The NIH, a part of the U.S. Department of Health and Human Services, is the primary federal agency for conducting and supporting medical research. The NIH invests more than $28 billion annually in medical research. More than 80 percent of the NIH's funding is awarded through nearly 50,000 competitive grants to more than 212,000 researchers at more than 2,800 universities, medical schools, and other research institutions nationwide and around the world.
For more information, visit www.nih.gov.
National Cancer Institute (NCI)
The NCI, established under the National Cancer Institute Act of 1937, is the federal government's principal agency for cancer research and training. NCI coordinates the National Cancer Program, which conducts and supports research, training, dissemination of health information, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
For more information, visit www.cancer.gov.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. It is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. This is achieved through researching and developing new biomedical imaging and bioengineering techniques and devices to improve the detection, treatment, and prevention of disease; enhancing existing imaging and bioengineering modalities; supporting related research in the physical and mathematical sciences; encouraging research and development in multidisciplinary areas; supporting studies to assess the effectiveness and outcomes of new biologics, materials, processes, devices, and procedures; developing technologies for early detection of disease and assessment of health status; and developing advanced imaging and engineering techniques for conducting biomedical research at multiple scales.
For more information, visit www.nibib.nih.gov.
Nuclear Regulatory Commission (NRC)
Regulatory authority over the use of ionizing radiation for medical purposes is shared among several federal, state, and local government agencies. NRC's jurisdiction has recently been expanded to include not only the possession and use of byproduct, source, or special nuclear material in medicine, but also naturally occurring and accelerator- produced materials.
NRC (or the responsible agreement state) regulates many activities associated with medical, industrial, and academic uses of nuclear materials. Medical uses within NRC's jurisdiction are: nuclear materials used to monitor, image, or treat metabolic processes or tissues in humans; material used in some calibration sources, radioactive drugs, bone mineral analyzers, portable fluoroscopic imaging devices, brachytherapy sources and devices, gamma stereotactical surgery devices, and teletherapy units used in medicine; and source material used for radiation shielding and counterweights in medical devices.
For more information, visit www.nrc.gov.
Key Organizations Influencing Regulatory Policy
Institute of Medicine/National Academy of Sciences (NAS)
The NAS was created by an Act of Congress to "investigate, examine, experiment, and report upon any subject of science or art" whenever called upon to do so by any department of the government. Subsequently, the Institute of Medicine was created as a component of the NAS to provide science-based advice on matters of biomedical science, medicine, and health.. Some of the recent and ongoing reports undertaken by these organizations include quality standards for breast imaging, production of medical isotopes, and the "state-of-the-science" review of nuclear medicine, among others.
National Council on Radiation Protection and Measurements (NCRP)
The NCRP was chartered by the U.S. Congress in 1964. NCRP's mission is to formulate and widely disseminate information, guidance, and recommendations on radiation protection and measurements that represent the consensus of leading scientific thinking. The Council is also responsible for facilitating and stimulating cooperation among organizations concerned with the scientific and related aspects of radiation protection and measurements.
International Commission on Radiological Protection (ICRP)
The ICRP is an independent not-for-profit organization established to advance the science of radiological protection by providing recommendations and guidance on all aspects of protection against ionizing radiation. ICRP offers its recommendations to regulatory and advisory agencies and provides advice intended to assist agency staff members who are responsible for radiological protection.