Department of Health and Human Services January 2011 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 329
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0138, ``Epidemic Intelligence Service Officers Files, HHS/CDC/OWCD.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Office of Workforce and Career Development (OWCD).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0137, ``Passport File, HHS/CDC/COGH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07- 16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Coordinating Office for Global Health (COGH), Office of Global Program Support Services.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0136, ``Epidemiologic Studies and Surveillance of Disease Problems, HHS/CDC/NCID.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0118, ``Study at Work Sites Where Agents Suspected of Being Occupational Hazards Exist, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07- 16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0117, ``Medical and Test Record Results of Individuals Involved in NIOSH Laboratory Studies, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information. To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Institute for Occupational Safety and Health (NIOSH).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0113, ``Epidemic Investigation Case Records, HHS/CDC/NCID.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0112, ``Fellowship Program and Guest Researcher Records, HHS/CDC/AHRC.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Atlanta Human Resources Center (AHRC), Scientific Resources Program, Material, Data and Specimen Handling Section.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0106, ``Specimen Handling for Testing and Related Data, HHS/CDC/NCID.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID), Scientific Resources Program, Material, Data and Specimen Handling Section.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0103, ``Alien Tuberculosis Follow-up Program, HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for HIV, STD and TB Prevention (NCHSTP).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0102, ``Alien Mental Waiver Program, HHS/CDC/ NCID. HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the National Center for Infectious Diseases (NCID), Division of Quarantine, Medical Screening and Health Assessment Branch, Medical Screening Section.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0096, ``Records of Tuskegee Study Health Benefit Recipients, HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memorandum (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0090, ``Studies of Testing for Tuberculosis and other Mycobacterioses, HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Division of Tuberculosis Elimination, National Center for HIV, STD and TB Prevention (NCHSTP).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0089, ``Studies of Treatment of Tuberculosis and other Mycobacterioses HHS/CDC/NCHSTP.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Division of Tuberculosis Elimination, National Center for HIV, STD and TB Prevention (NCHSTP).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0055, ``Administrative Files for Research/ Demonstration and Training Grants, and Cooperative Agreements Applications, HHS/CDC/PGO.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Procurement and Grants Office (PGO). Data is also occasionally located at contractor sites as studies are developed, data collected, and reports written. A list of contractor sites where individually identified data are currently located is available upon request to the system manager. Data is occasionally located at grantee sites as studies are developed, data collected, and reports written. A list of grantee sites where individually identified data is currently located is available upon request to the system manager.
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-20-0001, ``Certifying Interpreting Physician File, HHS/CDC/NIOSH.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Division of Respiratory Disease Studies (DRDS), National Institute for Occupational Safety and Health (NIOSH).
Privacy Act of 1974; Report of Modified or Altered System of Records
The Department of Health and Human Services proposes to alter System of Records, 09-19-0001, ``Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.'' HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information: To appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance. These records will be maintained by the Agency for Toxic Substances and Disease Registry (ATSDR), Coordinating Center for Environmental Health and Injury Prevention (CCEHIP), Division of Health Studies.
Independent Scientific Peer Review Panel Meeting on an In Vitro
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a public meeting of an independent scientific peer review panel (Panel) to evaluate the validation status of LUMI-CELL[supreg] ER (BG1Luc ER TA), an in vitro transcriptional activation (TA) assay used to identify chemicals that can interact with human estrogen receptors (ERs). Validated assays that can detect the interaction of chemicals with specific hormone receptors, including ERs, have been accepted and included in the U.S. Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program (EDSP) (https://www.epa.gov/endo/pubs/ assayvalidation/status.htm). Consequently, the BG1Luc ER TA may be applicable for addressing the ER TA component of the EPA EDSP Tier 1 screening battery. At this meeting, the Panel will review the draft BRD for the BG1Luc ER TA and evaluate the extent to which established validation and acceptance criteria have been appropriately addressed. The Panel also will be asked to comment on the extent to which the information included in the BRD supports ICCVAM's draft test method recommendations. NICEATM invites public comments on the draft BRD and draft ICCVAM test method recommendations. These documents are available on the NICEATM-ICCVAM Web site at: https://iccvam.niehs.nih.gov/methods/ endocrine/PeerPanel11.htm.
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 Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Directorwas 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).
Request for the Technical Review of the Draft Current Intelligence Bulletin (CIB): Derivation of Immediately Dangerous to Life and Health (IDLH) Values
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the draft, Current Intelligence Bulletin (CIB): Derivation of Immediately Dangerous to Life and Health (IDLH) Values. NIOSH is requesting technical review of the draft CIB. The draft document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/docket/review/docket156/default.html . Public Comment Period: Comments must be received by March 15, 2011. A public meeting to be convened either in Cincinnati, Ohio or via Teleweb may be scheduled at a date and time to be announced later if determined to be necessary. This public meeting will be announced via a subsequent notice.
The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability for public comment of a document for The National Antimicrobial Resistance Monitoring System (NARMS) entitled ``NARMS Strategic Plan 2011-2015.'' The document outlines the strategic goals and objectives for 2011 through 2015 of the NARMS program developed by the participating Agencies (FDA, the Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture (USDA)) based on recommendations of an External Subcommittee of the Science Board to FDA. The Agency is soliciting public comment on the goals and objectives in the Strategic Plan and whether the goals and objectives meet the recommendations of the subcommittee.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
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 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 request regarding the Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
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.
Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until February 23, 2011, the comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published in the Federal Register of August 9, 2010 (75 FR 47820). In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period to permit public consideration of late-received comments and to provide an opportunity for all interested parties to provide information and share views on the matter.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
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 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 procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
The ACBSCT will be conducting a conference call to discuss: (1) Final language of recommendations from November 15, 2010, Council meeting; and (2) Interim Report to Congress.
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