Research Highlights: Government Agencies
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U.S. Department Of Health And Human Services (DHHS)

Office of the National Health Information Technology Coordinator (ONCHIT)

In an Executive Order issued on April 27, 2004, President George W. Bush called for widespread deployment of health information technology within 10 years. As part of this announcement, he formed the Office of the National Coordinator for Health Information Technology. An important aspect of the President's initiative is the development of a nationwide interoperable health information technology infrastructure that can facilitate improvements in safety, quality, efficiency and care coordination.

National Institutes of Health

  • NIH Roadmap
    The NIH Roadmap provides a framework of the priorities the NIH as a whole must address in order to optimize its entire research portfolio. It lays out a vision for a more efficient and productive system of medical research and it identifies the most compelling opportunities in three main areas: new pathways to discovery, research teams of the future and re-engineering the clinical research enterprise.

    Initiatives under the NIH Roadmap will help enable the agency to sustain its historic record of cutting-edge contributions that are central to extending the quality of healthy life for people in this country and around the world.

National Cancer Institute

  • Radiation Oncology Sciences Program (ROSP)
    The ROSP is an umbrella organization designed to coordinate all radiation oncology activities and includes the Radiation Oncology Branch, the Radiation Biology Branch and the Radiation Research Program. The activities include intramural research, extramural activities and patient outreach, both domestic and international.

  • Radiation Research Program (RRP)
    The RRP is responsible for NCI's clinically-related extramural radiation research program. The RRP establishes priorities, allocates resources and evaluates the effectiveness of such radiation research being conducted by NCI grantees. RRP staff represent the program at NCI management and scientific meetings and provide scientific support to leadership on matters related to radiation research. The RRP coordinates its activities with other radiation research programs at NCI, NIH, other federal agencies and national and international research organizations, and it provides a focal point within NIH for extramural investigators concerned with clinically related radiation research.

  • Cancer Biomedical Informatics Grid (CaBiG)
    To expedite the cancer research communities' access to key bioinformatics platforms, NCI plans to deploy an integrating biomedical informatics infrastructure: the Cancer Biomedical Informatics Grid. In partnership with the cancer research community, NCI is creating a common, extensible informatics platform that integrates diverse data types and supports interoperable analytic tools. This platform will allow research groups to tap into the rich collection of emerging cancer research data while supporting their individual investigations.

  • Surveillance, Epidemiology and End Results (SEER) Program
    The SEER Program of NCI is an authoritative source of information on cancer incidence and survival in the United States. SEER began collecting data on cases on January 1, 1973, in the states of Connecticut, Iowa, New Mexico, Utah and Hawaii, and the metropolitan areas of Detroit and San Francisco-Oakland. In 1974-1975, the metropolitan area of Atlanta and the 13-county Seattle-Puget Sound area were added. In 1978, 10 predominantly black rural counties in Georgia were added, followed in 1980 by the addition of American Indians residing in Arizona. Three additional geographic areas participated in the SEER program prior to 1990: New Orleans, Louisiana (1974-1977, rejoined 2001); New Jersey (1979-1989, rejoined 2001); and Puerto Rico (1973-1989). The National Cancer Institute also funds a cancer registry that, with technical assistance from SEER, collects information on cancer cases among Alaska Native populations residing in Alaska. In 1992, the SEER Program was expanded to increase coverage of minority populations, especially Hispanics, by adding Los Angeles County and four counties in the San Jose-Monterey area south of San Francisco. In 2001, the SEER Program expanded coverage to include Kentucky and Greater California; in addition, New Jersey and Louisiana once again became participants.

    The SEER Program currently collects and publishes cancer incidence and survival data from 14 population-based cancer registries and three supplemental registries covering approximately 26 percent of the US population. Information on more than three million in situ and invasive cancer cases is included in the SEER database, and approximately 170,000 new cases are added each year within the SEER coverage areas. The SEER Registries routinely collect data on patient demographics, primary tumor site, morphology, stage at diagnosis, first course of treatment and follow-up for vital status. The SEER Program is the only comprehensive source of population-based information in the United States that includes stage of cancer at the time of diagnosis and survival rates within each stage. The mortality data reported by SEER are provided by the National Center for Health Statistics.

Food and Drug Administration (FDA)

  • Center for Devices and Radiological Health (CDRH)
    FDA's Center for Devices and Radiological Health is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. There are thousands of types of medical devices, from heart pacemakers to contact lenses. Radiation-emitting products regulated by FDA include microwave ovens, video display terminals, medical ultrasound and X-ray machines. The center accomplishes its mission by:

    • Reviewing requests to research or market medical devices.
    • Collecting, analyzing and acting on information about injuries and other experiences in the use of medical devices and radiation-emitting electronic products.
    • Setting and enforcing good manufacturing practice regulations and performance standards for radiation-emitting electronic products and medical devices.
    • Monitoring compliance and surveillance programs for medical devices and radiation-emitting electronic products.
    • Providing technical and other nonfinancial assistance to small manufacturers of medical devices.

Miscellaneous Reports

  • Innovation/Stagnation – Challenge and Opportunity on the Critical Path to New Medical Products
    The FDA issued this report to address the growing crisis in moving basic discoveries to the market where they can be made available to patients. The report evaluates how the crisis came about and offers a way forward. It highlights examples of agency efforts that have improved the critical path and discusses opportunities for future efforts. Finally, the report calls for a joint effort of industry, academia and FDA to identify key problems and develop targeted solutions.

    • The processing, content and evaluation of regulatory submissions.
    • The design, production, manufacturing and testing of regulated products.
    • The inspection and enforcement procedures.

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations or both.

 

Last updated on 2/26/2007 1:43:16 PM