Department of Health and Human Services August 1, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing the portions reflecting approval of a new animal drug application (NADA) for which FDA has withdrawn approval. NADA 140-828, sponsored by Bayer Corp., provides for use of enrofloxacin to treat poultry. In a notice published elsewhere in this issue of the Federal Register, FDA is announcing the availability of the final decision withdrawing approval of this NADA.

This notice is to inform interested parties of a correction made to the Head Start Family Literacy Project program announcement that was published on July 25, 2005. The following correction should be noted: Under Section IV. Application and Submission Information, 1. Address to Request Application Package, please delete the following phone number for The Dixon Group: 1-800-351-2293. Please replace the deleted phone number with the following: 1-866- 796-1591. All other information in this notice of correction is accurate and replaces information specified in the July 25 notice. Applications are still due by the deadline date that was published in the July 25 notice (due date for applications is September 8, 2005).

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the FD& C Act), as amended by the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA or PDUFA III)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts for application fees, establishment fees, and product fees for FY 2006 were established by PDUFA III. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the revenue levels established in the statute, after those amounts have been first adjusted for inflation and workload. This notice establishes fee rates for FY 2006 for application fees for an application requiring clinical data ($767,400), for an application not requiring clinical data or a supplement requiring clinical data ($383,700), for establishment fees ($264,000), and for product fees ($42,130). These fees are effective on October 1, 2005, and will remain in effect through September 30, 2006. For applications and supplements that are submitted on or after October 1, 2005, the new fee schedule must be used. Invoices for establishment and product fees for FY 2006 will be issued in August 2005, using the new fee schedule.

The Food and Drug Administration (FDA) is announcing a delay in the publication of the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006.