Department of Health and Human Services January 25, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Process Validation: General Principles and Practices.'' This guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements. This guidance revises and replaces the guidance for industry entitled ``Guideline on General Principles of Process Validation,'' dated May 1987.

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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

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: ``Synthesis Reports for Grants and Cooperative Agreements for Transforming Healthcare Quality through Information Technology (THQIT).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2, 2010 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.

The Department of Health and Human Services proposes to alter System of Records, 09-20-0170, National Select Agent Registry (NSAR)/ Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER''. 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 Terrorism Preparedness and Emergency Response (COTPER), Division of Select Agents and Toxins (DSAT).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0161, ``Records of Health Professionals in Disease Prevention and Control Training Programs, 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).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0159, ``Records of Subject in Certification, Testing, Studies of Personal Protective Devices, and Accident Investigations, 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), National Personal Protective Technology Laboratory (NPPTL).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0153, ``Mortality Studies in Coal Mining, Metal and Non-metal Mining and General Industry, 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).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, 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).

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.

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).

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).

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.

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.

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).

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.

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.