Department of Health and Human Services December 7, 2015 – Federal Register Recent Federal Regulation Documents

Moving Forward: Collaborative Approaches to Medical Device Cybersecurity; Public Workshop; Request for Comments
Document Number: 2015-30772
Type: Notice
Date: 2015-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.'' FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services, and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts; increase awareness of existing maturity models (i.e. frameworks leveraged for benchmarking an organization's processes) which are used to evaluate cybersecurity status, standards, and tools in development; and to engage the multi- stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development and Commercialization of Aza-Epoxy Guaiane Derivatives for Treatment of Renal Cancer
Document Number: 2015-30752
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to ElexiMed LLC, a company having a place of business at 5003 Green Mountain Circle, Suite 4, Columbia, MD 21044, USA, to practice the inventions embodied in the following patent applications. Intellectual PropertyPCT Patent Application No. PCT/US2015/ 014601, entitled ``Aza-Englerin AnaloguesNovel Natural Product-Based Nitrogen-Containing Anti-Cancer Agents'' filed February 5, 2015 (HHS Ref. No.: E-090-2014/2-PCT-01); US Provisional Patent Application No. 62/018,381, entitled ``Aza-epoxy-guaiane derivatives and treatment of cancer'' filed June 27, 2014 (HHS Ref. No. E-090-2014/ 1-US-01); and US Provisional Patent Application No. 61/936,285, entitled ``Aza-englerin analogues and use in cancer therapy'' filed February 5, 2014 (HHS Ref. No. E-090-2014/0-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America and the University of Hawaii. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development and commercialization of aza-epoxy guaiane derivatives for treatment of renal cancer.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, ElexiMed LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
National Institute on Aging; Notice of Meeting
Document Number: 2015-30751
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2015-30750
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2015-30749
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/inde x.html.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-30742
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2015-30719
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-30718
Type: Notice
Date: 2015-12-07
Agency: Department of Health and Human Services
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.