International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products" (66 FR 56332, November 7, 2001). It is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R).     

Medical devices; designation of special control for eight surgical suture devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" that identifies performance, testing, and labeling recommendations for the devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions on its own initiative because it believes they are necessary to provide reasonable assurance of the safety and effectiveness of surgical suture devices. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act).     

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule,Treasury decision

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.     

Reviewers for Volume 27

Editorial Board

Reviewers for Volume 27     

Author Index of Volume 16

Authors Index

Author Index of Volume 16     

Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this 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 a guidance document that will serve as the special control for the device.     

Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order

The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.     

Food labeling: health claims; D-tagatose and dental caries. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose as a substance eligible for the dental caries health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.