Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents
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Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule
This document adopts the Countermeasures Injury Compensation Program Administrative Implementation Interim Final Rule as the final rule with technical amendments. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to establish the Countermeasures Injury Compensation Program (CICP or Program). The Department of Health and Human Services (HHS) is issuing this final rule to adopt the administrative policies, procedures, and requirements for the CICP set out in the interim final rule, which was published and effective on October 15, 2010. This Program is designed to provide benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The Secretary makes only minor technical amendments to the interim final rule, described below, and otherwise adopts the regulation as published on October 15, 2010.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Revision of Performance Standards for State Medicaid Fraud Control Units
This notice seeks comment on an OIG proposal to revise standards for assessing the performance of the State Medicaid Fraud Control Units (MFCUs or Units). This proposal would replace and supersede standards published on September 26, 1994 (59 FR 49080).
Submission for OBM Review; Comment Request; New Proposed Collection, Environmental Science Formative Research Methodology Studies for the National Children's Study
Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for reinstatement of approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23603-23605, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. 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: Environmental Science Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Request: New. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act.'' FDA is issuing this guidance to provide answers to common questions that might arise about the new fee provisions and FDA's plans for their implementation in fiscal year (FY) 2012.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Center for Devices and Radiological Health; Standard Operating Procedures for Network of Experts; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of draft standard operating procedures (SOPs) for a new ``Network of Experts.'' The draft SOPs describe a new process for staff at the Center for Devices and Radiological Health (CDRH, the center) to gain access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise within the Center.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
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.
Proposed Collection; Comment Request; STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science)
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 Office of the Director of 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. Proposed Collection: Title: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science). Type of Information Collection Request: Reinstatement of OMB number 0925-0616, expiration date 01/31/2011. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The goal of STAR METRICS is to continue to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by Federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creation), on knowledge generation (such as citations and patents) as well as on social and health outcomes. Frequency of Response: Quarterly. Affected Public: Universities and other research institutions. Type of Respondents: University administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 100. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 2.5. Estimated Total Annual Burden Hours Requested: 1,315. The annualized cost to respondents is estimated to be $65,750. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
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.
Availability of Draft NTP Monograph on the Health Effects of Low-Level Lead; Request for Comments; Announcement of a Panel Meeting to Peer Review Draft Monograph
The NTP announces the availability of the Draft NTP Monograph on the Health Effects of Low-level Lead (available at https:// ntp.niehs.nih.gov/go/36639) that will be peer-reviewed by an NTP Peer Review Panel at a meeting on November 17-18, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft monograph (see Request for Comments below).
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA).
Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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.
Deborah Martinez Seldon: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Deborah Martinez Seldon from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Seldon was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Ms. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to respond constitutes a waiver of her right to a hearing concerning this action.
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