Department of Health and Human Services May 31, 2011 – Federal Register Recent Federal Regulation Documents

Medicare Program; Notification of Closure of St. Vincent's Medical Center
Document Number: 2011-13478
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the closure of St. Vincent's Medical Center and the initiation of an application process for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: 2011-13441
Type: Notice
Date: 2011-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
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 collection provisions of FDA's Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals.
Cooperative Arrangement Between the United States Food and Drug Administration and the Inter-American Institute for Cooperation in Agriculture
Document Number: 2011-13440
Type: Notice
Date: 2011-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between FDA and the Inter-American Institute for Cooperation in Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to facilitate the exchange of information and the development of projects of mutual interest.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13421
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA
Document Number: 2011-13388
Type: Notice
Date: 2011-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.
Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes
Document Number: 2011-13372
Type: Proposed Rule
Date: 2011-05-31
Agency: Department of Health and Human Services, Office of the Secretary
Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this rule proposes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also proposes to address the status of ONC- Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.
Public Health Service Act (PHS); Delegation of Authority
Document Number: 2011-13371
Type: Notice
Date: 2011-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of the Director Amended Notice of Meeting
Document Number: 2011-13353
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, National Institutes of Health
President's Committee for People With Intellectual Disabilities; Notice of Correction of Room for Meeting
Document Number: 2011-13337
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-13333
Type: Notice
Date: 2011-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13330
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-13328
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2011-13300
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act
Document Number: 2011-13297
Type: Proposed Rule
Date: 2011-05-31
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's standard for accounting of disclosures of protected health information. The purpose of these modifications is, in part, to implement the statutory requirement under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to require covered entities and business associates to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record. Pursuant to both the HITECH Act and its more general authority under HIPAA, the Department proposes to expand the accounting provision to provide individuals with the right to receive an access report indicating who has accessed electronic protected health information in a designated record set. Under its more general authority under HIPAA, the Department also proposes changes to the existing accounting requirements to improve their workability and effectiveness.
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