Department of Health and Human Services June 10, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially Harmful Constituents’ in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act”; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ```Harmful and Potentially Harmful Constituents' in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff on certain provisions of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use of `Light,' `Mild,' `Low,' or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products.'' This guidance provides information on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) requirements related to the use of ``light,'' ``mild,'' ``low,'' or similar descriptors in the label, labeling, or advertising of tobacco products. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): Availability of the Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
NICEATM announces the availability of the Biennial Progress Report 2008-2009: Interagency Coordinating Committee on the Validation of Alternative Methods. In accordance with requirements of the ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 42 U.S.C. 285l-3(e)(7)), this report describes progress and activities during 2008-2009 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Corrections
This document corrects technical and typographical errors in the final rule that appeared in the April 15, 2010 Federal Register entitled ``Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.''
Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA
The Food and Drug Administration (FDA) has determined the regulatory review period for PROMACTA 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.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 024
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 024'' (Recognition List Number: 024), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
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