Department of Health and Human Services October 26, 2018 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBINYN 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Biopharmaceutics Classification System-Based Biowaivers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance will provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of in vivo bioequivalence (BE) studies for drug products. In vivo BE studies are needed to demonstrate lack of impact of significant formulation changes on a drug's bioavailability during its development, for post-approval line extensions, and when developing a generic product. Utilizing the critical properties of the drug substance and the drug product, and applying the BCS framework, assurance of in vivo BE findings can be obtained using extensive in vitro studies. The draft guidance is intended to avoid unnecessary human BE trials based on extensive in vitro characterization of the drug substance and drug product properties.

The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for a revised draft product-specific guidance on Sucralfate that appeared in a notice of availability, published in the Federal Register of October 20, 2017. In that notice, FDA requested comments on the revised draft guidance for industry on Sucralfate, as well as comments on other product-specific guidances. FDA is reopening the comment period for the Draft Guidance on Sucralfate (revised October 2017) to facilitate submission of comments pertaining to this draft guidance following an FDA response to two citizen petitions. The petition response suggests that the petitioners submit to the docket comments relating to the guidance.