Department of Health and Human Services January 8, 2013 – Federal Register Recent Federal Regulation Documents

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-00136
Type: Notice
Date: 2013-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2013-00127
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-00089
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00088
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-00087
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support
Document Number: 2013-00086
Type: Proposed Rule
Date: 2013-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
On its own initiative, based on new information, the Food and Drug Administration (FDA) is proposing to reclassify membrane lung devices for long-term pulmonary support, a preamendments class III device, into class II (special controls) for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because circuit components used with the oxygenator are to be subject to the same regulatory controls, all of the device components used in an ECMO procedure are being considered in the scope of this proposed order, and the title and identification of the regulation will be revised accordingly to include extracorporeal circuit and accessories for long- term pulmonary/cardiac support.
Cardiovascular Devices; Reclassification of External Cardiac Compressor
Document Number: 2013-00085
Type: Proposed Rule
Date: 2013-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00065
Type: Notice
Date: 2013-01-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00031
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Information Collection Activity; Comment Request
Document Number: 2012-31714
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
Regulatory Agenda
Document Number: 2012-31671
Type: Unknown
Date: 2013-01-08
Agency: Department of Health and Human Services, Department of Homeland Security, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.
Semiannual Regulatory Agenda
Document Number: 2012-31497
Type: Unknown
Date: 2013-01-08
Agency: Department of Energy, Department of Health and Human Services
The Department of Energy (DOE) has prepared and is making available its portion of the semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions (Agenda), including its Regulatory Plan (Plan), pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' and the Regulatory Flexibility Act.