Department of Health and Human Services April 9, 2009 – Federal Register Recent Federal Regulation Documents
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Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date
The Food and Drug Administration (FDA) is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``Substances Prohibited From Use in Animal Food or Feed,'' published in the Federal Register on April 25, 2008 (73 FR 22720). That rule established measures to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). FDA has become aware that some affected persons, particularly those in the rendering industry, are experiencing difficulties modifying their operations to comply with the new requirements contained in the April 25, 2008 final rule and, therefore, may not be in full compliance by the April 27, 2009, effective date. Accordingly, the FDA is proposing this action to delay the effective date of the April 25, 2008, final rule for 60 days until June 26, 2009. FDA is providing 7 days for public comment solely on the question of whether to delay the effective date.
Fiscal Year (FY) 2009 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $500,000 (total costs) per year for up to two years to Case Management, Inc. (CMI), Memphis, TN. This is not a formal request for applications. Assistance will be provided only to Case Management, Inc. (CMI) based on the receipt of a satisfactory application that is approved by an independent review group.
Medical Devices; Order for Certain Class III Devices; Submission of Safety and Effectiveness Information
The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA a summary of, and a citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information concerning the devices which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring the submission of this information in order to determine, for each device, whether the classification of the device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol (PDP), or whether the device should be reclassified into class I or II.
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