Department of Health and Human Services February 25, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated February 2008. The guidance document provides recommendations to sponsors for using methods other than sterility testing to confirm the integrity of container and closure systems as part of stability testing for sterile biological products, human and veterinary drugs, and medical devices. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility. The guidance announced in this notice finalizes the draft guidance entitled ``Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated January 1998.
Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta- glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of CHD'' to include barley betafiber as another eligible source of beta-glucan soluble fiber.
Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a ``draft final'' document, pending approval by the Office of Management and Budget (OMB) of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh- cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to- eat form.
Combe, Inc.; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that Combe, Inc., has filed a petition proposing that the color additive regulations be amended to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
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