Department of Health and Human Services March 23, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Announcement of Requirements and Registration for Beat Down Blood Pressure Challenge
The Office of the National Coordinator for Health Information Technology (ONC), in partnership with Million Hearts, an HHS initiative to prevent a million heart attacks and strokes in five years, announces the launch of the Beat Down Blood Pressure Video Challenge. This challenge is an open call for the public to create and submit short, compelling videos sharing how they use health IT or consumer e-health tools to manage high blood pressure. Health care providers are also encouraged to apply to demonstrate how they use electronic health records and other health IT to manage their patients' high blood pressure. This is the second in a series of Health IT video contests that will occur throughout 2012. The goal of this video contest series is to generate content that will be used to motivate and inspire others to leverage technology to be more engaged partners in improving their health and health care. Each challenge will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular theme, and will award cash prizes to winners in several categories.
Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector
The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations
We are publishing this companion proposed rule to the direct final rule on ``Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations,'' which makes technical changes intended to update a requirement that many of these agreements and memoranda of understanding (MOUs) be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This proposed rule, accordingly, would eliminate it. We are proposing these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations
This direct final rule makes technical changes that will update a requirement that many of our written agreements and memoranda of understanding (MOUs) with other departments, Agencies, and organizations be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This direct final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents. We are proceeding in accordance with our direct final rule procedures. We are publishing a companion proposed rule under our usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event we receive any significant adverse comments and withdraw this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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 collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).
Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.
Medicare and Medicaid Programs; Application From Det Norske Veritas Healthcare (DNVHC) for Continued Approval of Its Hospital Accreditation Program
This proposed notice with comment period acknowledges the receipt of an application from Det Norske Veritas Healthcare (DNVHC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), May 2, 2012
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued CMS-Approval of its Home Health Agency Accreditation Program
This notice announces our decision to approve the Community Health Accreditation Program (CHAP) for recognition as a national accreditation program for home health agencies (HHAs) seeking to participate in the Medicare or Medicaid programs.
Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors and Risk Adjustment
This final rule implements standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (``Exchanges'') are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce uncertainty by sharing risk in the individual market through making payments for high claims costs for enrollees. The temporary Federally administered risk corridors program serves to protect against uncertainty in rate setting by qualified health plans sharing risk in losses and gains with the Federal government. The permanent State-based risk adjustment program provides payments to health insurance issuers that disproportionately attract high-risk populations (such as individuals with chronic conditions).
Medicaid Program; Eligiblity Changes Under the Affordable Care Act of 2010
This final rule implements several provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges (``Exchanges''), and the assurance of coordination between Medicaid, CHIP, and Exchanges. This final rule codifies policy and procedural changes to the Medicaid and CHIP programs related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs.
Medicare and Medicaid Programs; Approval of the Application by the American Association for Accreditation of Ambulatory Surgery Facilities for Deeming Authority for Rural Health Clinics
This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accreditation program for rural health clinics (RHCs) seeking to participate in the Medicare or Medicaid programs.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
