Department of Health and Human Services September 13, 2012 – 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) permanently debarring Lisa Jean Sharp from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Lisa Jean Sharp was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the FD&C Act. Ms. Sharp was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, but failed to respond. Ms. Sharp's failure to respond constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2013.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices.'' FDA is co-sponsoring the workshop together with the AGS, a nonprofit organization that supports glaucoma specialists and scientists through the advancement of education and research. The purpose of this public workshop is to provide a forum for discussing the validity, reliability, and usability of glaucoma imaging devices. The primary topic to be discussed relates to imaging of the posterior segment of the eye (e.g., retinal nerve fiber layer, optic nerve head, ganglion cell layer) using Optical Coherence Tomography (OCT, time domain and spectral domain), with particular emphasis on normative databases and the diagnostic performance of OCT for therapeutic glaucoma products (regulatory considerations) and clinical decision making (clinical practice considerations).

This final rule modifies the Department of Health and Human Services (HHS) regulations for medical examinations of underground coal miners. Existing regulations established specifications for providing, interpreting, classifying, and submitting film-based roentgenograms (now commonly called chest radiographs or X-rays) of underground coal miners. The revised standards modify the requirements to permit the use of film-based radiography systems and add a parallel set of standards permitting the use of digital radiography systems. An additional amendment requires coal mine operators to provide the National Institute for Occupational Safety and Health (NIOSH) with employee rosters to assist the Coal Workers' Health Surveillance Program in improving participation by miners.