Department of Health and Human Services October 23, 2018 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration's (FDA) Center for Devices and Radiological Health, Office of Device Evaluation recognizes that an efficient, risk-based approach to regulating ophthalmic Optical Coherence Tomography (OCT) technology will foster innovation designed to improve ophthalmic healthcare. To make premarket review of OCT devices more efficient, we are announcing a new voluntary OCT Premarket Notification (510(k)) Pilot Program, designed to develop and refine individual premarket testing recommendations for OCT devices through the pre-submission process to yield more consistent premarket submissions and improve predictability of the 510(k) review process. We are planning to achieve these goals through increased interactive engagement with manufacturers of OCT devices. FDA intends to use the voluntary OCT 510(k) Pilot Program to assess whether the individual testing recommendations provided through the pre-submission process and increased interactive engagement improve the premarket review process and reduce the overall total time to decision (TTD), a shared FDA- industry commitment goal, in support of the Medical Device User Fee Amendments of 2017.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NUPLAZID 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 drug product.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.