Department of Health and Human Services May 1, 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ashley Brandon Foyle for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Foyle was convicted of introducing and delivering for introduction into interstate commerce a misbranded drug, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for Mr. Foyle's conviction undermines the process for the regulation of drugs. Mr. Foyle was given notice of the proposed debarment and an opportunity to request a hearing within the prescribed timeframe by regulation but failed to respond. Mr. Foyle's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 23, 2013 from 1:00 to 3:30 p.m. at the Lister Hill Center Auditorium (Building 38A), National Library of Medicine, on the NIH Campus at 8600 Rockville Pike, Bethesda, MD 20894. The meeting is open to the public.

The Health Resources and Services Administration (HRSA) will be issuing a non-competitive award of $250,000 under the Health Center Program (section 330 of the Public Health Service Act.) that will be awarded to West End Medical Center, Inc. (WEMC), Atlanta, Georgia, during the budget period June 1, 2012, through May 31, 2013. This award will support the delivery of primary care services in Gwinnett County, Georgia, to prevent a disruption in services.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Inspection by Accredited Persons Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``NIOSH Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers'' [2013-145].

The number of cancer survivors in the United States is currently estimated at 14 million and is expected to increase significantly with the aging of the United States population. Cancer survivors may experience a host of long-term and late effects that require coordinated follow-up care after completion of primary treatment for cancer. Despite significant progress in cancer treatment, the complex, often fragmented state of end-of-treatment care may lead to harmful breakdowns in patient-provider communication and follow-up care for cancer survivors. Enabling better communication, exchange of data, and care coordination can help improve end-of-treatment consultations and care planning for cancer survivors. Innovative new approaches are needed to assist patients and their support networks use information from their providers and care plans to facilitate cancer follow-up care that is comprehensive, coordinated, and of high-quality. To address the needs of cancer survivors, the Office of the National Coordinator for Health Information Technology (ONC) is launching the Crowds Care for Cancer: Supporting Survivors Challenge in conjunction with the National Cancer Institute (NCI) as part of the Investing in Innovation (i2) program. This challenge aims to incentivize the development of innovative information management tools and applications that help survivors manage their transition from specialty to primary care; for example, by facilitating activities such as coordinating recommendations, appointments, and resources from patient support networks and healthcare providers involved in their care. Submissions should help survivors use information from their providers and survivorship care plans to improve communication and coordination within their care networks that can help facilitate the planning and delivery of coordinated, high-quality, and patient- centered follow-up care. These networks often include families, friends, and members of their primary and specialty care teams. The ultimate goal of this challenge is to develop applications that will better meet the needs of cancer survivors. Finalists from Phase I will garner seed funding and publicity from ONC and NCI to assist qualified entrants in developing applications ready for solicitation of additional development resources.