Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 3,846
Early Retiree Reinsurance Program
This notice announces that CMS, based on the projected availability of funding under the Early Retiree Reinsurance Program (ERRP), is exercising its authority under the ERRP regulations at 45 CFR 149.45(a) to deny ERRP reimbursement requests, in their entirety, that include claims that are incurred after December 31, 2011. Therefore, plan sponsors must not include such claims in their Claim Lists and Summary Cost Data submitted in support of a reimbursement request. Should circumstances related to the availability of ERRP funding change, CMS may issue a new notice announcing approval of ERRP reimbursement request that include claims incurred after December 31, 2011.
Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program
This final rule implements the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The goal of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Submission for OMB Review; Comment Request; The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT Tools
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Research Center, 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, September 8, 2011, Volume 76, Number 174, page 55690, 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. Potential persons who are to respond to the collection of information are not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT tools. Type of Information Collection Request: NEW. Need and Use of Information Collection: The Epidemiology and Biostatistics section in RMD will be collecting information through a contractor (Boston University- Health and Disability Research Institute (BU-HDR)) and subcontractor for validation of the Computer Adaptive Tests which are being developed to assist in the SSA disability determination process. The utilization of CAT technology could potentially allow the SSA to collect more relevant and precise data about human functioning in a faster, more efficient fashion. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as ``permanently disabled''. Individuals will complete the CAT tools for the functional domains of Physical Demands and Interpersonal Interactions along with established legacy instruments. For the domain of physical function, individuals will complete the BU-HDR CAT; the PROMIS Item Bank v 1.0-Physical Functioning (copyright) PROMIS Health Organization and PROMIS Cooperative Group; and, The Short Form (36) Health SurveyTM (SF-36). For the domain of interpersonal interactions, individuals will complete the BU-HDR CAT, the SF-36 and the BASIS-24(copyright) (Behavior and Symptom Identification Scale). Data collected will be used to validate the BU-HDR CAT tools. Without this information, completion of the BU-HDR CAT tools will not be possible. Frequency of Response: Once. Affected Public: Individuals who have opted in to participate in web surveys through a survey research firm. Type of Respondents: Adults who indicate ``permanently disabled'' as a working status. The annual reporting burden is as follows:
U.S. National Authority for the WHO Global Code of Practice on the International Recruitment of Health Personnel; Notice of Public Meeting
In order to support the United States' implementation of the WHO Global Code of Practice on the International Recruitment of Health Personnel, notice is hereby given of the following meeting to update and engage interested parties in U.S. implementation efforts.
Availability of Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data From the Island of Vieques, Puerto Rico
This notice announces the availability of the Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data from the Island of Vieques, Puerto Rico for review and comment. This report's principal focus is to review updated environmental data on Vieques air, water, soil, seafood, and locally grown foods. In addition, this report evaluates human biomonitoring and health outcome data. ATSDR is providing a public comment period for this draft report as a means to best serve public health and the residents of Vieques, Puerto Rico. The Draft Vieques Report is available in English and Spanish at www.regulations.gov in the docket identified by Docket ID No. CDC-2011- 0014 and www.atsdr.cdc.gov/sites/vieques/.
New Animal Drugs for Use in Animal Feeds; Tilmicosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The supplemental NADA provides for use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease in groups of beef and nonlactating dairy cattle.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Comparative Direct-to-Consumer Advertising
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Listing of Members of the Food and Drug Administration's Senior Executive Service Performance Review Board
The Food and Drug Administration (FDA) is publishing a list of members who may be named to serve on FDA's Senior Executive Performance Review Board or Panels, which oversee the evaluation of performance appraisals of FDA's Senior Executive Service (SES) members. The Civil Service Reform Act of 1978 requires that the appointment of Performance Review Board Members be published in the Federal Register.
Prospective Grant of Exclusive License: Use of Agents Targeting Thrombospondin-1 and CD47 To Treat Radiation-Induced Damage and Enhance the Effectiveness of Radiotherapy in Cancer Patients
This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/850,132, filed October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. Provisional Patent Application No. 60/864,153, filed November 02, 2006, now abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional Patent Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E-227-2006/3-US-01); U.S. Provisional Patent Application No. 60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E-227- 2006/4-US-01); PCT Patent Application No. PCT/2007/080647, filed October 5, 2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. Patent Application No. 12/444,364, filed April 3, 2009 (HHS Ref. No. E- 227-2006/5-US-02); Canadian Patent Application No. 2,665,287, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-CA-03); Australian Patent Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E-227- 2006/5-AU-04); European Patent Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-EP-05); U.S. Provisional Patent Application No. 61/086,991, filed August 7, 2008, now abandoned (HHS Ref. No. E-153-2008/0-US-01); PCT Patent Application No. PCT/2009/ 052902, filed August 5, 2009, now abandoned (HHS Ref. No. E-153-2008/0- PCT-02); U.S. Patent Application No. 13/057,447, filed February 3, 2011 (HHS Ref. No. E-153-2008/0-US-06); Canadian Patent Application No. 2732102 filed August 5, 2009 (HHS Ref. No. E-153-2008/0-CA-043); Australian Patent Application No. 2009279676, filed August 5, 2009 (HHS Ref. No. E-153-2008/0-AU-03); and European Patent Application No. 09791202.6, filed August 5, 2009 (HHS Ref. No. E-153-2008/0-EP-08), entitled ``Prevention of Tissue Ischemia, Related Methods and Compositions,'' and ``Radioprotectants Targeting Thrombospondin-1 and CD47,'' to Radiation Control Technologies, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive license territory may be ``worldwide,'' and the field of use may be limited to: (1) The use of morpholino oligonucleotides that reduce expression of CD47 in combination with radiotherapy, to treat or prevent cancers in humans; and (2) the use of morpholino oligonucleotides that reduce expression of CD47 to treat or prevent radiation exposure damage in humans.
Government-Owned Inventions; Licensing and Collaborative Research Opportunity: Chemotoxins for Targeted Treatment of Diseased Cells
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.
Government-Owned Inventions; Availability for Licensing
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.
Nominations to the Advisory Committee on Blood Safety and Availability
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services (HHS). Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of HHS for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Biologics Price Competition and Innovation Act of 2009; Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Notice of Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.
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