Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) Extended-Release Tablet products approved under new drug application (NDA) 21-610 were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended-release tablets if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel avian influenza A(H7N9) virus. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad that involves the novel avian influenza A(H7N9) virus. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel avian influenza A(H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on toluene diissocyanate (TDI) and other TDI-based isocyanate products to develop a Criteria Document to establish an updated Recommended Exposure Limit (REL) for toluene diisocyanate. The current NIOSH REL for 2,4-TDI is the lowest feasible concentration with no ceiling due to the potential carcinogenicity of 2,4-TDI. NIOSH is requesting information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with toluene diisocyanate; (2) information on possible health effects observed in workers exposed to toluene diisocyanate, including exposure data and the method(s) used for sampling and analyzing exposures; (3) description of work tasks and scenarios with a potential for exposure to toluene diisocyanate; (4) information on control measures (e.g. engineering controls, work practices, personal protective equipment, exposure data before and after implementation of control measures) that are being used in workplaces with potential exposure to toluene diisocyanate; and (5) surveillance findings including protocol, methods, and results.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2013.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single-source application for the award of a cooperative agreement in fiscal year 2013 (FY13) to the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station Poultry Unit located in Salisbury, NC. Egg-associated illness due to Salmonella is a major public health concern, with table eggs being the primary source of Salmonella Enteritidis. Therefore, an FDA priority is to implement preventative measures to reduce the vertical and horizontal transmission of Salmonella Enteritidis and other Salmonella serovars to table eggs and poultry products. The goal of this collaborative project between FDA and the North Carolina State University, Prestage Department of Poultry Science and the Piedmont Research Station is to utilize a commercial research facility to parallel the transmission (vertical and horizontal) of Salmonella found within the egg-production industry and how alterations in physical feed characteristics and housing may influence vertical and horizontal transmission. Additionally, this study aims to examine how commercially utilized disinfection protocols affect horizontal transmission of Salmonella in alternative versus traditionally housed layer hens. Moreover, this study may reveal other serovars of Salmonella present within the commercial egg industry which may pose a potential health risk to consumers. While historically the concern over Salmonella has focused on Salmonella Enteritidis, there is a potential concern that other Salmonella serovars could be a source for egg-transmitted human salmonellosis. Hence, this study aims to investigate the occurrence, transmission, and virulence of varying Salmonella serovars.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on planning for the effects of high absenteeism to ensure availability of medically necessary drug products.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Evaluation of FDA's General Market Youth Tobacco Prevention Campaigns.