Department of Health and Human Services June 22, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``General Principles for Evaluating the Safety of Compounds Used in Food- Producing Animals (GFI 3).'' This version of the guidance replaces the version that was made available in July 1994. This has been revised to remove outdated information on toxicological testing and to provide references to other available guidance on the topic. In addition, the document has been revised to address minor formatting issues.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations authorizing the use of vitamin D3 as a nutrient supplement in calcium-fortified fruit juices and fruit drinks, excluding fruit juices and fruit juice drinks specially formulated or processed for infants, at levels not to exceed 100 International Units (IU) per serving. (In the final rule, FDA used the term ``fruit drink;'' however, the common or usual name of the product is ``fruit juice drink.'' Therefore, FDA is replacing the term ``fruit drink'' with ``fruit juice drink.'') In response to one of the objections, FDA is amending the vitamin D3 regulation to replace the current 100 IU per serving limits on the vitamin D3 fortification of fruit juices and fruit juice drinks with limits of 100 IU per 240 milliliters (mL). This document also corrects three errors that appeared in the codified portion of the vitamin D3 final rule.
Notice of Funding Availability for State Partnership Grant Program To Improve Minority Health
This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2005 funding for the State Partnership Grant Program To Improve Minority Health.
Guidance for Industry and Food and Drug Administration: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile; Availability
The Food and Drug Administration (FDA or agency) is announcing the availability of a revised guidance document entitled ``Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.'' The guidance explains that FDA has established a list that is provided to the government of Chile and posted on FDA's Internet site, which identifies U.S. dairy product manufacturers that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (e.g., injunction or seizure) or a pending warning letter. Application for inclusion on the list is voluntary. However, Chile has advised that dairy products from firms not on this list could be delayed or prevented by Chilean authorities from entering commerce in Chile. The revised guidance document describes the recommended process for U.S. manufacturers to follow to be included on the list and explains FDA's request, on Chile's behalf, that this information be updated every 2 years.
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