Department of Health and Human Services August 5, 2011 – Federal Register Recent Federal Regulation Documents
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Notice of Scientific Summit; The Science of Compassion-Future Directions in End-of-Life and Palliative Care
Notice is hereby given that the National Institute of Nursing Research (NINR), National Institutes of Health (NIH), Department of Health and Human Services, will convene a scientific summit titled ``The Science of CompassionFuture Directions in End-of-Life and Palliative Care.'' The summit is cosponsored by the NIH Office of Rare Diseases Research, the NIH Office of Research on Women's Health, the National Center for Complementary and Alternative Medicine, the National Institute on Aging, and the NIH Clinical Center Department of Bioethics. Portions of the event are supported by the Foundation for the National Institutes of Health and Pfizer.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Sheng Wang, PhD, Boston University School of Medicine Cancer Research Center: Based on the Respondent's acceptance of ORI's research misconduct findings, ORI found that Dr. Sheng Wang, who has been an Assistant Professor, Department of Medicine, Boston University School of Medicine Cancer Research Center (BUSM), engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA102940 and R01 CA101992. ORI found that the Respondent engaged in research misconduct by fabricating data that were included in two (2) published papers:
National Institutes of Health; Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 26, 2008 (Vol. 73, No. 124, page 36337) and allowed 60 days for public comment. No public comments were received. 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 3. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 25 minutes. Estimated Total Annual Burden Hours Requested: 450.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand FDA's thinking on compliance with the positron emission tomography drugs (PET) CGMP regulations, including appropriate resources, procedures, and documentation for PET drug production facilities.
Fiscal Year (FY) 2011 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $3,800,000 (total costs) for up to one year to the National Council for Behavioral Healthcare. This is not a formal request for applications. Assistance will be provided only to the National Council for Behavioral Healthcare based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-11-013.
Award of Replacement Grant for Preventive Health to Lutheran Social Services of North Dakota, Fargo, ND
In Fiscal Year 2006, in an effort to assist States and local health departments to ensure that newly arriving refugees have access to preventive health screenings, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Division of Refugee Assistance (DRA) awarded, through competition, a Refugee Preventive Health grant to the North Dakota Department of Human Services for a project period of July 1, 2006 to June 30, 2011. The North Dakota Department of Human Services has relinquished the grant. ORR announces the award of a single-source replacement grant to Lutheran Social Services of North Dakota of Fargo, ND, a non-profit organization engaged in the resettlement of refugees, to continue services under the Refugee Preventive Health grant. Services provided under the grant to Lutheran Social Services of North Dakota are within the scope and operation of the original award, and address the preventive health needs of refugees in their first year in the United States. The program includes initial health screening, treatment of immediate health needs, follow up on chronic illnesses, nursing case management, interpretation services and preventive health education. The project period for the award is July 1, 2010 to June 30, 2011.
Indian Alcohol and Substance Abuse Memorandum of Agreement Between U.S. Department of Health and Human Services (DHHS), U.S. Department of the Interior (DOI), and U.S. Department of Justice (DOJ)
This serves as notice that the Department of Health and Human Services (DHHS), the Department of the Interior (DOI), and the Department of Justice (DOJ), have entered into a Memorandum of Agreement (MOA), pursuant to the Indian Alcohol and Substance Abuse Treatment Act of 1986 (the Act), as amended by the Tribal Law and Order Act of 2010 (TLOA).
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units
This final rule will implement section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a 2 percent reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This final rule will also update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification and weighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are also consolidating, clarifying, and revising existing policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhance consistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Order entitled ``Improving Regulation and Regulatory Review,'' we are amending existing regulatory provisions regarding ''new'' facilities and changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and remove obsolete material.
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