Department of Health and Human Services April 5, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls guidance document for each of the 11 devices. These draft guidance documents describe a means by which these devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate special controls for each of these devices and would exempt six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act). These draft guidance documents are not final nor are they in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) is announcing the availability of five documents related to FDA's continuing assessment of Bisphenol A (BPA) and soliciting public comments on the four documents prepared by FDA's Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm ). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.