Department of Health and Human Services November 5, 2015 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Development of Therapeutics To Treat Brain Injury and Neurodegenerative Disease
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Astrocyte Pharmaceuticals, Inc., (``Astrocyte''), a company incorporated under the laws of Delaware and having an office in Cambridge, Massachusetts, to practice the following inventions embodied in the following patent applications: US Provisional Patent Appl. No. 60/176,373 entitled, ``Methanocarba cycloalkyl nucleoside analogues,'' filed 14 Jan 2000 [HHS reference E-176-1999/0-US-01]; Intl. Appl. No. PCT/US01/00981, entitled, ``Methanocarba cycloalkyl nucleoside analogues,'' filed 12 Jan 2001 [HHS reference E-176-1999/0-PCT-02]; Australia Patent No. 2001230913, issued 13 Oct 2005 [HHS reference E- 176-1999/0-AU-03]; Canada Patent No. 2.397,366, issued 15 Mar 2011 [HHS reference E-176-1999/0-CA-04]; European Patent Appl. No. 01903043.6 entitled, filed 12 Jan 2001 [HHS Ref No E-176-1999/0-EP-05]; US Patent No. 7,087,589, issued 8 Aug 2006 [HHS reference E-176-1999/0-US-06]; US patent No. 7,790,735, issued 8 Aug 2006 [HHS reference E-176-1999/0-US- 07]; and Great Britain patent No. 1252160, issued 16 Aug 2006 [HHS reference E-176-1999/0-US-08]. The patent rights in these inventions have been assigned to the United States of America. The territories included in this license may be worldwide. The field of use may be related to ``Use of the patent rights in the development and sale of therapeutics for cerebral trauma, stroke, and neurodegenerative disorders.''
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the evaluation of the progress of CDC partners that receive awards distributed via contracts, grants and cooperative agreements, from the Procurements and Grants Office (PGO). PGO is responsible for the stewardship of these funds while providing excellent, professional services to our partners and stakeholders. Data will be collected for the purpose of evaluating the progress of programmatic activities.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the Laboratory Response Network information collection.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement.'' CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.
Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.'' The draft guidance is intended for institutions and IRBs that are responsible for the review and oversight of human subject research conducted or supported by the U.S. Department of Health and Human Services (HHS) or regulated by FDA. The purpose of the draft guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The draft guidance also provides general recommendations on the type and amount of information to be included in the minutes.
Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
This final rule will update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this rule implements the 3rd year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provides a clarification regarding the use of the ``initial encounter'' seventh character applicable to certain ICD-10-CM code categories. This final rule will also finalize reductions to the national, standardized 60-day episode payment rate in CY 2016, CY 2017, and CY 2018 of 0.97 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014. In addition, this rule implements a HH value-based purchasing (HHVBP) model, beginning January 1, 2016, in which all Medicare-certified HHAs in selected states will be required to participate. Finally, this rule finalizes minor changes to the home health quality reporting program and minor technical regulations text changes.
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