Department of Health and Human Services February 9, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pharmacogenetic Tests and Genetic Tests for Heritable Markers.'' This draft guidance document is intended to provide guidance on preparing and reviewing premarket approval applications (PMAs) and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests).

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.'' It was developed as a special control to support the reclassification of intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls). This draft guidance document describes a means by which these intervertebral body fusion devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the intervertebral body fusion device that contains bone grafting material from class III into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. This draft guidance is not final, nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.'' The guidance document describes a means by which these in vitro diagnostic devices for the laboratory diagnosis of hepatitis A virus (HAV) may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls). HAV serological assays are in vitro diagnostic devices used to test for specific antibodies to support the clinical laboratory diagnosis of HAV.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC, Animal Health Division. The supplemental NADA provides for the use of flavored, chewable praziquantel/pyrantel pamoate/febantel tablets for the removal of several species of internal parasites in dogs.

The Indian Health Service published a document in the Federal Register on December 30, 2005. The document contained an error.

This notice announces the second meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the second meeting of the American Health Information Community Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).