Department of Health and Human Services September 15, 2014 – Federal Register Recent Federal Regulation Documents

Proposed Information Collection Activity; Comment Request
Document Number: 2014-21918
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2014-21917
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-21909
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21885
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-21881
Type: Notice
Date: 2014-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2014-21859
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-21858
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2014-21857
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-21856
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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.
Prospective Grant of Exclusive Evaluation License: Development of Antibody-Drug Conjugates Comprising Topoisomerase Inhibitors for the Treatment of Human Cancers
Document Number: 2014-21855
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/844,027 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2006 [HHS Ref. No. E- 160-2006/0-US-01], PCT Application No. PCT/US2007/078233 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E-160-2006/0-PCT-02], European Patent Application No. 7842310.0 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E- 160-2006/0-EP-03], and U.S. Patent Application No. 12/441,029 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed March 12, 2009 now US Patent No. 8,008,316 issued August 30, 2011 [HHS Ref. No. E-160-2006/0-US-04], and all related continuing and foreign patents/patent applications for the technology family, to Oncolinx, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the development and use of the licensed patent rights as a component of an antibody-drug conjugate for the treatment of human cancers. Upon expiration or termination of the exclusive evaluation option license, Oncolinx will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-21854
Type: Notice
Date: 2014-09-15
Agency: Department of Health and Human Services
Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices
Document Number: 2014-21816
Type: Proposed Rule
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Withdrawal of Draft Guidance
Document Number: 2014-21815
Type: Notice
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of the draft guidance entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator,'' dated October 2011, in response to the requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) and new input received during a panel meeting.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
Document Number: 2014-21814
Type: Proposed Rule
Date: 2014-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the device identification and reclassify the pacing system analyzers (PSAs) into class II (special controls). Specifically, single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are postamendments class III devices, are proposed to be reclassified to class II devices. FDA is proposing this reclassification based on new information pertaining to the device. This proposed action would implement certain statutory requirements.