Department of Health and Human Services May 1, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Agency Emergency Processing Under the Office of Management and Budget Review; MedWatch-The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). This notice solicits comments on a proposal for the MedWatch program to deploy and conduct a web-based customer satisfaction survey of certain health care professional trade and specialty organizations that voluntarily have chosen to participate in the FDA MedWatch's Partners program. The survey will solicit information about the utility of the FDA MedWatch safety alerts and monthly safety labeling changes that are posted on the MedWatch Web site and disseminated to partner organizations for sharing with members of the organizations.
Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended-Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' The Medical Device User Fee and Modernization Act 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance identifying the circumstances in which the name, abbreviation, or symbol of the manufacturer of an original device is not ``prominent and conspicuous.'' MDUFSA requires that FDA issue guidance no later than 180 days after the date of enactment (August 1, 2005).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Research Study Complaint Form
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Research Study Complaint Form'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues
This proposed rule would implement competitive bidding programs for certain covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act (the Act). These programs would change the way that Medicare pays for these items under Part B of the Medicare program by utilizing bids submitted by DMEPOS suppliers to establish applicable payment amounts. We would phase in these programs over several years. This proposed rule would also detail requirements for CMS approved accreditation organizations that will be applying quality standards for all DMEPOS suppliers, including DMEPOS suppliers that participate in the DMEPOS competitive bidding program. In addition, this rule proposes a new fee schedule for home dialysis supplies and equipment still paid on a reasonable charge basis. This proposed rule would also clarify our policy on the scope of the statutory eyeglass coverage exclusion. We are proposing to specify in regulations that the eyeglass exclusion encompasses all devices that use lenses to aid vision or provide magnification of images for impaired vision. Further, this proposed rule would implement a revised methodology for calculating fee schedule amounts for new DMEPOS items.
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