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

Pursuant to Section 1322 of the Affordable Care Act entitled, ``Federal Program to Assist Establishment and Operation of Nonprofit, Member-Run Health Insurance Issuers,'' this notice announces the second meeting of an advisory committee to the Secretary in accordance with the Federal Advisory Committee Act. The meeting is open to the public. The purpose of the meeting is to assist and advise the Secretary and Congress through the Department of Health and Human Services' (the Department's) Office of Consumer Information and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified nonprofit health insurance issuers. Specifically, the Committee shall advise the Secretary and Congress concerning the award of grants and loans related to Section 1322 of the Affordable Care Act. In these matters, the Committee shall consult with all components of the Department, other Federal entities, and non-Federal organizations, as appropriate; and examine relevant data sources to assess the grant and loan award strategy to provide recommendations to OCIIO. Notice of this meeting is given under the Federal Advisory Committee Act.

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.

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: ``Understanding Development Methods from Other Industries to Improve the Design of Consumer Health IT.'' 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 rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for discharges occurring during the rate year beginning July 1, 2011 through September 30, 2012. The proposed rule would also change the IPF prospective payment system (PPS) payment rate update period to a rate year (RY) that coincides with a fiscal year (FY). In addition, the rule proposes policy changes affecting the IPF PPS teaching adjustment. It would also rebase and revise the Rehabilitation, Psychiatric, and Long-Term Care (RPL) market basket, and make some clarifications and corrections to terminology and regulations text.

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: ``Standardizing Antibiotic Use in Long-term Care Settings.'' 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 15th, 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 Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ``Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010'' dated August 2010, that was announced in the Federal Register of August 25, 2010. FDA now intends to complete the notice and comment rulemaking process for the Patient Protection and Affordable Care Act of 2010 (hereinafter ``section 4205'') before initiating enforcement activities based, in part, on extensive comments on the draft guidance submitted to the Agency. FDA believes that this approach to implementing section 4205 will minimize uncertainty and confusion among all interested persons.

This notice announces changes to the Health Information Technology Extension Program, which assists providers seeking to adopt and become meaningful users of health information technology, as authorized under section 3012(c) of the Public Health Service Act, as added by the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (ARRA).

The U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) published the January 25, 2011 Public Meeting notice under exceptional circumstances. The meeting notice was published in the Federal Register on January 13, 2011. This supplemental notice provides the reasons for providing less than 15 calendar days notice.

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: ``The Agency for Healthcare Research and Quality (AHRQ) Health Care Innovations Exchange Innovator Interview and Innovator Email Submission Guidelines.'' 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 2nd, 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, 09-20-0171, ``Quarantine and Traveler Related Activities, including Records for Contract Tracing Investigation and Notification under 42 CFR Parts 70 and 71, HHS/CDC/CCID.'' 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 Center for Infectious Diseases (CCID), Division of Global Migration and Quarantine, National Center for the Preparedness, Detection, and Control of Infectious Disease (NCPDCID).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0162, ``Records of Subjects in Agent Orange, Vietnam Experience, and Selected Cancers Studies, HHS/CDC/CCEHIP/ NCEH.'' 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 Center for Environmental Health and Injury Prevention (CCEHIP), National Center for Environmental Health (NCEH).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0160, ``Records of Subjects in Health Promotion and Education Studies, HHS/CDC/NCCDPHP.'' HHS is proposing adding 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 Chronic Disease Prevention and Health Promotion (NCCDPHP), Coordinating Center for Health Promotion

The Department of Health and Human Services proposes to alter System of Records, 09-20-0154, ``Medical and 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).

The Department of Health and Human Services proposes to alter System of Records, 09-20-0149, ``Morbidity 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).