Department of Health and Human Services August 2, 2006 – Federal Register Recent Federal Regulation Documents

This notice announces the development of Set 20 Toxicological Profiles. Set 20 Toxicological Profiles consists of one new draft and six updated drafts. These profiles will be available to the public on or about October 17, 2006.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic 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 (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 2007 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 2007 for application fees for an application requiring clinical data ($896,200), for an application not requiring clinical data or a supplement requiring clinical data ($448,100), for establishment fees ($313,100), and for product fees ($49,750). These fees are effective on October 1, 2006, and will remain in effect through September 30, 2007. For applications and supplements that are submitted on or after October 1, 2006, the new fee schedule must be used. Invoices for establishment and product fees for FY 2007 will be issued in August 2006, using the new fee schedule.

The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to collect user fees for certain medical device applications. The FY 2007 fee rates are provided in this notice. For all applications submitted on or after October 1, 2006, and through September 30, 2007, fees must be paid at the FY 2007 rates at the time the applications are submitted to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your check is received. This notice provides details on how fees for FY 2007 were determined and payment procedures for medical device applications subject to user fees.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Assessment of Unreimbursed Care among Community Primary Care Physicians.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.