Department of Health and Human Services October 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 330
Request for Public Comment: 30-Day Proposed Information Collection: Office of Urban Indian Health Programs; Uniform Data System
In compliance with Section 3507 of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (74 FR 59544) on November 18, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: Office of Urban Indian Health Programs (OUIHP) Uniform Data System (UDS). Type of Information Collection Request: Initial request and four-year extension, for data collection to ensure compliance with legislative mandates and report to Congress and policymakers on program accomplishments. Form Number(s): There are currently no form numbers. Reporting formats are contained in the UDS Instruction Manual. Need and Use of Information Collection: The UDS contains the annual reporting requirements for the cluster of primary health care and case management/outreach and referral grantees funded by the IHS. The UDS includes reporting requirements for grantees of the OUIHP. The authorizing statute is Title V of Public Law 94-437, of the Indian Health Care Improvement Act, as amended. IHS will collect data in the UDS which will be used to ensure compliance with the legislative mandates and report to Congress and policymakers on program accomplishments. To meet these objectives, the OUIHP requires a core set of data collected annually that is appropriate for monitoring and evaluating performance and reporting on annual trends. Affected Public: Title V funded urban Indian health programs. Type of Respondents: Title V urban Indian health programs. The table below provides: Types of data collection instruments, Number of respondents, Responses per respondent, Total annual responses, Average burden hours per response, and Total annual burden hours.
Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Hospice Services
This proposed rule would revise the requirements that an institution would have to meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or as a nursing facility (NF) in the Medicaid program. We are proposing these requirements to ensure that long-term care (LTC) facilities (that is, SNFs and NFs) that chose to arrange for the provision of hospice care through an agreement with one or more Medicare-certified hospice providers would have in place a written agreement with the hospice that specified the roles and responsibilities of each entity.
Public Meeting To Discuss NIOSH's Respirator Standards Development Efforts
The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), will conduct a public meeting to discuss current respirator standards development projects, including the NIOSH Regulatory Agenda for updating 42 CFR part 84, CBRN Combination Unit Respirator Performance Requirements, and the NIOSH policy on SCBA ``Buddy-Breathing''. There will be an opportunity for discussion following each topic's presentations.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from Revere Copper and Brass, Detroit, Michigan, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 6, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Blockson Chemical Company in Joliet, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 3, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 6, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Science Board to FDA, Office of the Commissioner, Office of Chief Scientist. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Arcadia Biosciences, Inc.; Filing of Food Additive Petition (Animal Use); Safflower Seed Meal
The Food and Drug Administration (FDA) is announcing that Arcadia Biosciences, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of seed meal from a variety of bioengineered safflower in cattle and poultry feeds.
Components for Evaluation of Direct-Reading Monitors for Gases and Vapors and Addendum
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft publication for public comment. The document and its addendum are entitled, respectively, ``Components for Evaluation of Direct-Reading Monitors for Gases and Vapors'' and ``Addendum to Components for Evaluation of Direct-Reading Monitors for Gases and Vapors: Hazard Detection in First Responder Environments.'' The draft documents and instructions for submitting comments can be found at: https://www.cdc.gov/niosh/docket/ review/docket220. The document expands the 1995 method development and evaluation experimental testing methods to direct-reading monitors for gases and vapors. These Components are provided for laboratory users, consensus standard setting bodies, and manufacturers of direct-reading instrumentation and are compatible with the Instrumentation, Systems, and Automation Society guidelines. The addendum to the document expands the applicability of the Components by presenting methods to be used in evaluating direct-reading monitors for hazard detection in First Responder environments. The 1995 document, entitled ``Guidelines for Air Sampling and Analytical Method Development and Evaluation,'' can be viewed at: https://www.cdc.gov/niosh/docs/ 95-117/. This guidance does not have the force and effect of the law.
Determination That BUSPAR (Buspirone Hydrochloride) Tablets, 10 Milligrams, 15 Milligrams, and 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that BUSPAR (buspirone hydrochloride) Tablets, 10 milligrams (mg), 15 mg, and 30 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
National Toxicology Program (NTP); Office of Liaison, Policy and Review Meeting of the NTP Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Medical Device User Fees; Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of August 13, 2010 (75 FR 49502). In the notice, FDA requested input and comments from interested stakeholders on the Agency's medical user fee program and requested suggestions regarding the commitments FDA should propose for the next reauthorized program. The Agency is taking this action to allow interested persons additional time to submit comments.
Proposed Collection; Comment Request; the NIH-American Association for Retired Persons (AARP) Interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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.
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.
Meeting of the Task Force on Community Preventive Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Task Force on Community Preventive Services (Task Force). The Task Force is an independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
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.
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