Department of Health and Human Services December 12, 2013 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 213 entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry 209.'' The purpose of this document is to provide information to sponsors of certain antimicrobial new animal drug products who are interested in revising conditions of use for those products consistent with FDA's Guidance for Industry (GFI) 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines for stakeholders wishing to comply voluntarily with this guidance.
Veterinary Feed Directive
The Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA's VFD program.
Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations
The Food and Drug Administration (FDA) is presenting Booz Allen Hamilton's high priority recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 to 2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The high priority recommendations are the first of a series of deliverables, as outlined in the contract statement of work,\2\ to be published as part of Phase 1 of the assessment.
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