Department of Health and Human Services May 7, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Developmental Disabilities Protection and Advocacy Program Performance Report
The Adminstration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Labeling Improvement and Enhancement Initiative
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection for the Prescription Drug Labeling Improvement and Enhancement Initiative (the initiative); specifically, information collection associated with the use of Government contractor-assisted labeling conversion resources and services for certain older drug and biological products (approved before June 30, 2001). The intent of the initiative is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling.
Agency Information Collection Activities; Proposed Collection; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements.'' This study will investigate the impact of price comparison information in direct-to-consumer (DTC) and health care professional advertising for prescription drugs.
Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published November 29, 2010.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2015
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2015 (for discharges occurring on or after October 1, 2014 and on or before September 30, 2015) as required by the statute. We are also proposing to collect data on the amount and mode (that is, Individual, Group, and Co-Treatment) of therapy provided in the IRF setting according to therapy discipline, revise the list of impairment group codes that presumptively meet the ``60 percent rule'' compliance criteria, provide for a new item on the Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI) form to indicate whether the prior treatment and severity requirements have been met for arthritis cases to presumptively meet the ``60 percent rule'' compliance criteria, and revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP). In this proposed rule, we also address the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), for the IRF prospective payment system (PPS), effective when ICD-10-CM becomes the required medical data code set for use on Medicare claims and IRF-PAI submissions.
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