Department of Health and Human Services January 21, 2015 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to Biohaven Pharmaceuticals Holding Company having its principal place of business in New Haven, Connecticut. The contemplated license would be for the inventions claimed in U.S. Utility Patent Number 8,859,585, issued October 14, 2014 (filed May 25, 2005), PCT Patent Application Number PCT/US2006/19335, filed May 18, 2006, U.S. Patent Application Number 14/478,442, filed September 5, 2014, European Patent Number 1896025, issued December 28, 2011 (and validated in Germany, France, and the United Kingdom), and Canadian Patent Number 2610025, issued July 22, 2014 (filed May 28, 2006). In addition, inventions claimed in any future applications claiming priority to or benefit of these patents and patent applications would also be subject to any license granted pursuant to this Notice. The patent rights in this invention have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License Agreement may be worldwide and the field of use may be limited to use of scopolamine for treatment of neuropsychiatric indications.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twentieth meeting on February 5-6, 2015. At this meeting, the Commission will conclude discussions related to the BRAIN Initiative and ongoing work in neuroscience, and begin discussions about the ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Treatments for Fecal Incontinence, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

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 information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.