Department of Health and Human Services October 23, 2007 – Federal Register Recent Federal Regulation Documents

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 21st set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``FY 2008 Medical Device User Fee Small Business Qualification and Certification.'' This guidance explains how a business headquartered in the United States or headquartered in a foreign nation may respectively qualify as ``small business'' under the medical device user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act). A ``small business'' may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a premarket approval application (PMA), biologics license application (BLA), product development protocol (PDP), or premarket report (PMR)).