Department of Health and Human Services December 15, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.

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) 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 collection of information associated with the Agency's Voluntary Cosmetic Registration Program (VCRP).

The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).

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 (PRA).

This notice announces a Town Hall Meeting to discuss the Physician Quality Reporting System (previously known as the Physician Quality Reporting Initiative (PQRI)). The purpose of the Town Hall Meeting is to solicit input from participating stakeholders on the individual quality measures and measures groups being considered for possible inclusion in the proposed set of quality measures for use in the 2012 Physician Quality Reporting System and key components of the design of the Physician Quality Reporting System. Measure developers, eligible professionals, professionals associations, such as medical specialty societies, and other interested stakeholders are invited to participate, in person or by teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available.