Department of Health and Human Services January 27, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 37 of 37
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
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.
Drug-Induced Liver Injury: Are We Ready to Look?; Public Conference; Request for Comments
The Food and Drug Administration (FDA) is announcing a public conference entitled ``Drug-Induced Liver Injury: Are We Ready to Look?'' The public conference will be cosponsored with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America to discuss and debate issues regarding drug-induced liver injury (DILI). The purpose of this conference is to consider the effect of the recommendations in the guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation'' since its publication in July 2009 and to seek suggestions for future revision.
Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
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 requirements under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications
The Food and Drug Administration (FDA) is announcing that a collection of information entitle ``Pretesting of Tobacco Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Approval of Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Regulatory Site Visit Training Program
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
The Consumer Operated and Oriented Plan (CO-OP) Advisory Board, February 7, 2011
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.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Rate Year Beginning July 1, 2011 (RY 2012)
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.
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