Department of Health and Human Services November 9, 2012 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey
Document Number: 2012-27445
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center Department of Bioethics, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 28, 2011 on page 72955-72956 [FR DOC 2011-30548] and allowed 60-days for public comment. Two comments were received by the NIH Department of Bioethics. The comments we received included one request from a survey firm that was interested in possibly administering the survey, and one request from the American Association of Medical Colleges (AAMC) that was interested in knowing what items were in the survey instrument. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: This survey is intended to collect information about the ethical dilemmas that surgeons have faced in their practices over the past year, and assess their experiences, if any, with their hospital consultation services. Specifically, the information gathered in this study will be valuable in understanding the ethical dilemmas that surgeons face, the utility of institution ethics consultations services for surgeons, and to identify what barriers, if any, discourage surgeons from utilizing these services. The results of this study can be used by medical professionals, hospitals, and bioethicists in several important ways. First, they will provide a better understanding the ethical dilemmas that surgeons face in their practices. Second, they will provide understanding of factors that determine the current utilization of hospital consultation services by surgeons. Third, information collected on the barriers to surgeons' use of ethics consultation services will provide better insight into the perspective and culture of surgery as it relates to ethical dilemmas in their practices and how ethics consultation services could better support surgeons when faced with these dilemmas. Frequency of Response: Once. Affected Public: Individuals; Businesses or other for-profit. Type of Respondents: Individuals. The annual reporting burden is as follows:
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-27430
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Amended Notice of Meeting
Document Number: 2012-27429
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-27428
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2012-27427
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2012-27426
Type: Notice
Date: 2012-11-09
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. 207 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.
Announcement of Physical Activity Guidelines Mid-Course Report Availability and Public Comment Period
Document Number: 2012-27425
Type: Notice
Date: 2012-11-09
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the availability of the Physical Activity Guidelines for Americans (PAG) Mid-course Report and solicits written comments on the draft report. A subcommittee of the President's Council on Fitness, Sports and Nutrition (PCFSN) was convened to complete the PAG Mid- course Report. The subcommittee was tasked with reviewing the evidence on intervention strategies that have been shown to be effective in increasing physical activity among youth ages 3-17. The report is a review-of-reviews which highlights research from a variety of settings in which physical activity can successfully be implemented for youth, including school, community, preschool/childcare, home/family, and primary care settings. In addition, the report identifies areas for future research. The intent of this report is to serve as a complement to the Physical Activity Guidelines for Americans, 2008 which recommends that youth ages 6-17 engage in at least 60 minutes of physical activity each day and provides strategies for increasing physical activity in youth toward meeting the PAG. Although the PAG did not include specific recommendations for youth younger than age 6, the PAG Mid-course Report includes intervention strategies in the preschool/childcare setting. This is a response to new science on physical activity among young children and supports HHS' efforts through Healthy People 2020 to promote physical activity in childcare settings. The subcommittee has completed its draft report and is soliciting public comment before the report is presented to PCFSN for deliberation, and subsequent submission to the Secretary, HHS.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2012
Document Number: 2012-27422
Type: Notice
Date: 2012-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
Document Number: 2012-27368
Type: Notice
Date: 2012-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Availability
Document Number: 2012-27340
Type: Notice
Date: 2012-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Bad Debt Reductions for All Medicare Providers
Document Number: 2012-26903
Type: Rule
Date: 2012-11-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2013. This rule also sets forth requirements for the ESRD quality incentive program (QIP), including for payment year (PY) 2015 and beyond. In addition, this rule implements changes to bad debt reimbursement for all Medicare providers, suppliers, and other entities eligible to receive Medicare payment for bad debt and removes the cap on bad debt reimbursement to ESRD facilities. (See the Table of Contents for a listing of the specific issues addressed in this final rule.)
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