Department of Health and Human Services April 7, 2011 – Federal Register Recent Federal Regulation Documents
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Update of the 2003 Interagency Quantitative Assessment of the Relative Risk to Public Health From Foodborne Listeria Monocytogenes Among Selected Categories of Ready-to-Eat Foods; Request for Comments, Scientific Data and Information
The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are requesting comments and scientific data and information that would assist the agencies in their plan to update a risk assessment on the relationship between foodborne Listeria monocytogenes in selected categories of ready-to-eat (RTE) foods and human health. The purpose of the risk assessment is to incorporate newly available scientific data and information into the risk assessment in order to update estimates of the relative risk of illness and death associated with the consumption of different types of RTE foods that may be contaminated with L. monocytogenes and to evaluate the relative effectiveness of strategies to reduce or prevent exposure to L. monocytogenes from the consumption of RTE foods, including, for example, the impact of changing refrigerated time and temperature storage prior to consumption.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the short- term (10 year) projection methods and assumptions in projecting Medicare health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Date: April 12, 2011, 9 a.m. to 5 p.m. e.t.
Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the establishment of six Staffs: Executive Operations and Strategic Planning Staff, Regulatory Science Staff, Regulatory Affairs Staff, Program Management and Analysis Staff, Project Management Staff, and Technical Information Staff. It will also include Office of Medication Error Prevention and Risk Management (OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under OSE. OMEPRM will consist of the Division of Risk Management and the Division of Medication Error Prevention and Analysis. OPE will consist of the Division of Epidemiology I and Division of Epidemiology II and the Division of Pharmacovigilance I and Division of Pharmacovigilance II. Also included are the abolishment of Business Process Improvement Staff, Regulatory Policy Staff, and Review Management Staff within OSE Immediate Office.
Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia): Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Ms. Chatman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Ms. Chatman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Chatman failed to respond. Ms. Chatman's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2011 Final Wage Indices Implementing the Medicare and Medicaid Extenders Act
This notice contains the final fiscal year (FY) 2011 wage indices and hospital reclassifications and other related tables which reflect changes required by or resulting from the implementation of section 102 of the Medicare and Medicaid Extenders Act of 2010. MMEA requires the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2011.
Medicare Program; Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center
Section 1899(f) of the Social Security Act (of the Act), as added by the Affordable Care Act (ACA) authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act (the Medicare Shared Savings Program). This notice with comment period describes and solicits public input regarding possible waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involving accountable care organizations (ACOs) under the Medicare Shared Savings Program. In addition, section 1115A(d)(1) of the Act, as added by section 3021 of the ACA, authorizes the Secretary to waive the same fraud and abuse laws, among others, as necessary solely for the purposes of carrying out the provisions of section 1115A of the Act with respect to the testing of certain innovative payment and service delivery models by the Center for Medicare and Medicaid Innovation. This notice with comment period also solicits public input regarding that separate waiver authority.
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations
This proposed rule would implement section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs). Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additional payments based on meeting specified quality and savings requirements.
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