Department of Health and Human Services October 19, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Assessing Consumer Perceptions of Health Claims.'' The meeting will present research assessing consumers' reactions to health claims and will address the implications of these studies for future research designed to evaluate consumer understanding of health claims and the effect of health claims on consumer perceptions and behaviors.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatHuman Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling using the electronic common technical document (eCTD) specifications. The submission of these documents in electronic format should improve the agency's efficiency in processing, archiving, and reviewing them.

The Food and Drug Administration (FDA) is proposing to amend its regulations to provide for the use of fluid ultrafiltered milk (UF) in the manufacture of standardized cheeses and related cheese products. This action responds principally to two citizen petitions: One submitted by the American Dairy Products Institute (ADPI) and another submitted jointly by the National Cheese Institute (NCI), the Grocery Manufacturers of America, Inc. (GMA), and the National Food Processors Association (NFPA). FDA tentatively concludes that this action will promote honesty and fair dealing in the interest of consumers and, to the extent practicable, will achieve consistency with existing international standards of identity for cheeses and related cheese products.