Department of Health and Human Services June 13, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs.

The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.

This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2009, which will be effective on January 1, 2009. The meeting will address technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting.