Department of Health and Human Services August 6, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined that Daranide (dichlorphenamide) Tablets, 50 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dichlorphenamide tablets, 50 mg.

This document corrects several technical and typographical errors in the proposed rule that was issued on July 2, 2007 and appeared in the July 12, 2007 Federal Register (72 FR 38122). The proposed rule addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2008. The proposed rule also addressed refinements to relative value units (RVUs) and physician self-referral issues. Specifically, the errors pertain to the following provisions: Drug compendia, telehealth services, competitive acquisition program (CAP), end-stage renal disease (ESRD), physician self-referral issues, therapy standards and requirements, Physician Quality Reporting Initiative, and the payment impact on physician fee schedule services.

The Food and Drug Administration (FDA) has determined that PHOSLO (calcium acetate) 667-milligram (mg) tablet, equal to 169 mg calcium, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcium acetate 667-mg tablet.