Department of Health and Human Services October 25, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this document were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (``Lookback'')'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the list of proposed substances that will be evaluated for CERCLA Set 22 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.

The Food and Drug Administration (FDA) is issuing this notice to explain the new direct-to-consumer (DTC) user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year (FY) 2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008. The information gathered in response to this notice will be used to establish the FY 2008 fee that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA.