Department of Health and Human Services June 18, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for BYSTOLIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA), Center for Tobacco Products is announcing that it is hosting a Web-based public meeting to discuss issues regarding the development of an enforcement action plan to enforce restrictions on promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities. FDA is seeking participation in the Web-based public meeting and data, information, and views from all interested parties, including, but not limited to, public health organizations, minority community groups and leaders, other stakeholders with demonstrated expertise and experience in serving minority communities, groups serving youth, patient groups, advertising agencies, the regulated industry, and other interested parties. This Web-based public meeting and the data, information, and views we receive are intended to help FDA in developing an enforcement action plan. FDA is seeking input on a number of specific issues, but is interested in other pertinent information as well.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), is giving public notice that the agency proposes to request reinstatement of an information collection activity for which approval expired on February 28, 2010.