Department of Health and Human Services January 30, 2006 – Federal Register Recent Federal Regulation Documents
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Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration
The Food and Drug Administration (FDA, we) is proposing to revise its requirements for cochineal extract and carmine by requiring their declaration on the label of all food and cosmetic products that contain these color additives. The proposed rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract and carmine-containing food and cosmetics and would allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This proposed action also responds, in part, to a citizen petition submitted by the Center for Science in the Public Interest (CSPI). With regard to drug products, FDA plans to initiate rulemaking to implement the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.105-115) provisions that require declaration of inactive ingredients for drugs. The FDAMA provisions have already been implemented for over-the-counter (OTC) drugs.
Determination of Regulatory Review Period for Purposes of Patent Extension; XOLAIR
The Food and Drug Administration (FDA) has determined the regulatory review period for XOLAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ENABLEX
The Food and Drug Administration (FDA) has determined the regulatory review period for ENABLEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Collection; Comment Request Evaluation of the Impact of the New Conflicts of Interest Regulations on the National Institutes of Health's Ability To Recruit and Retain Staff
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Human Resources (OHR) of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the office of Management and Budget (OMB) for review and approval.
American Health Information Community Electronic Health Record Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
American Health Information Community Meeting
This notice announces the fourth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
American Health Information Community Chronic Care Workgroup Meeting
This notice announces the first 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.).
Amendment To Extend the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures, as Amended on January 24, 2004 and January 24, 2005
Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures is revised to incorporate statutory definitions from the Smallpox Emergency Personnel Protection Act of 2003 and extended for one year until and including January 23, 2007.
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