Department of Health and Human Services March 5, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Adrian Vela: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adrian Vela for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Vela was convicted of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Vela was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 3, 2012 (30 days after receipt of the notice), Mr. Vela had not responded. Mr. Vela's failure to respond constitutes a waiver of his right to a hearing concerning this action.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)” (VICH GL36(R)); Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI 159) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI),'' (VICH GL36(R)). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.
Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III) and to incorporate additional types of communication, all of which increase the efficiency of the review process. This draft guidance is not final nor is it in effect at this time.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on “Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing” (VICH GL23(R)); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GFI 116) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)). This draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the Federal Register of January 4, 2002, and has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this draft revised VICH guidance the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is being revised. The draft revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the the following three tests: An in vitro chromosomal aberrations test using metaphase analysis, which detects both clastogenicity and aneugenicity; an in vitro mammalian cell micronucleus test, which detects the activity of clastogenicity and aneugenicity; or a mouse lymphoma test, which, with modification, can detect both gene mutation and chromosomal damage. This draft revised VICH guidance document is intended to facilitate the mutual acceptance of safety data necessary for the establishment of acceptable daily intakes for veterinary drug residues in human food by the relevant regulatory authorities.
Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and for Information
In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders and other interested parties an opportunity to submit comments and information that will help the Agency as it forms its own recommendations, to be contained in the Agency's report to Congress, and as it implements the FSMA provisions relating to the tracking and tracing of food.
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