Department of Health and Human Services January 10, 2007 – Federal Register Recent Federal Regulation Documents

Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays; Availability
Document Number: E7-120
Type: Notice
Date: 2007-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' This guidance document describes a means by which quality control material for cystic fibrosis nucleic acid assays may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify quality control material for cystic fibrosis nucleic acid assays into class II (special controls). This guidance document is being immediately implemented as the special control for quality control material for cystic fibrosis nucleic acid assays, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
Document Number: E7-119
Type: Rule
Date: 2007-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
New Animal Drugs; Change of Sponsor
Document Number: E7-118
Type: Rule
Date: 2007-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 14 approved new animal drug applications (NADAs) from ADM Animal Health & Nutrition Division to ADM Alliance Nutrition, Inc.