Department of Health and Human Services November 19, 2008 – Federal Register Recent Federal Regulation Documents

Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability
Document Number: E8-27466
Type: Notice
Date: 2008-11-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Group that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-27448
Type: Notice
Date: 2008-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
Document Number: E8-27436
Type: Rule
Date: 2008-11-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: E8-27381
Type: Notice
Date: 2008-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: E8-27358
Type: Notice
Date: 2008-11-19
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-27257
Type: Notice
Date: 2008-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
Document Number: E8-26213
Type: Rule
Date: 2008-11-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also finalizes the calendar year (CY) 2008 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2009. In addition, as required by the statute, it announces that the physician fee schedule update is 1.1 percent for CY 2009, the preliminary estimate for the sustainable growth rate for CY 2009 is 7.4 percent, and the conversion factor (CF) for CY 2009 is $36.0666. This final rule with comment period also implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). (See the Table of Contents for a listing of the specific issues addressed in this rule.)