,,ii #aadth ,,congress #ast ,session ,s4 #fba ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #b1 #bjae,mrs4 ,feinstein 7for herself1 ,ms4 ,collins1 ,mrs4 ,gillibrand1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure the safety and effectiveness of medically important antimicrobials approved for use in the prevention and control of animal diseases1 in order to minimize the development of antibiotic-resistant bacteria4 #a4 ,short title ,this ,act may be cited as the ,preventing ,antibiotic ,resistance ,act of #bjae4 #b4 ,purpose ,the purpose of this ,act is to ensure the safety and effectiveness of medically important antimicrobials approved for use in the prevention and control of animal diseases1 in order to minimize the development of antibiotic-resistant bacteria4 #c4 ,evidence of safety of medically important veterinary antimicrobials 7a7 ,applications pending or submitted after enactment ,section #eab7;d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7d77#a77 is amended-- 7#a7 in the first sentence-- 7,a7 in subparagraph 7,h71 by striking or at the end2 7,b7 in subparagraph 7,i71 by inserting or at the end2 and 7,c7 by inserting after subparagraph 7,i7 the following3 7,j7 with respect to a medically important antimicrobial 7as defined in subsection 7q771 the applicant has failed to demonstrate that a ,new ,animal ,drug ,application for an antimicrobial labeled for disease prevention or control fails to meet the criteria in subsection 7q77#b77;,a72 2 and 7#b7 in the second sentence1 by striking 7,a7 through 7,i7 and inserting 7,a7 through 7,j74 7b7 ,ensuring judicious use in animals of medically important antimicrobials ,section #eab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7 is amended by adding at the end the following3 7q7 ,ensuring judicious use in animals of medically important antimicrobials 7#a7 ,applicability ,this subsection applies to medically important antimicrobials approved for use in a food-producing animal-- 7,a7 7i7 for which there is in effect an approval of an application or an exemption under subsection 7b71 7i71 or 7j7 of section #eje2 or 7ii7 that is otherwise marketed for human use2 7,b7 for which the ,food and ,drug ,administration has initiated or completed withdrawal or modification of an approved label for growth promotion1 feed efficiency1 or other production use or over-the-counter use1 in accordance with the ,guidance for ,industry entitled1 ,new ,animal ,drugs and ,new ,animal ,drug ,combination ,products1 ,administered in or on ,medicated ,feed or ,drinking ,water of ,food-,producing ,animals3 ,recommendations for ,drug ,sponsors for ,voluntarily ,aligning ,product ,use ,conditions with ,,gfi #bji1 published in ,december #bjac2 and 7,c7 for which the ,food and ,drug ,administration has approved a label-- 7i7 for disease control or prevention at the same or similar dosage level as applicable for the approved production use described in subparagraph 7,b72 7ii7 that does not specify an explicitly defined duration of therapy2 or 7iii7 specifying a dosage that is not expected to treat a specific bacterial pathogen4 7#b7 ,review of disease prevention and control approvals 7,a7 ,in general ,not later than ,january #a1 #bjag1 the ,secretary shall initiate a process whereby-- 7i7 not later than ,january #a1 #bjah1 a sponsor of an antimicrobial drug described in paragraph 7#a7 shall submit to the ,secretary evidence demonstrating that1 with respect to such drug-- 7,i7 there is evidence of effectiveness in controlling or preventing bacterial disease2 7,,ii7 an approved use is consistent with accepted veterinary practice2 7,,iii7 an approved use is linked to a specific etiologic agent2 7,,iv7 an approved use is appropriately targeted to animals at risk of developing a specific bacterial disease2 7,v7 an approved use has an explicitly defined duration of therapy2 and 7,,vi7 there is reasonable certainty of no harm to human health due to the development of antimicrobial resistance2 and 7ii7 7,i7 if the ,secretary determines that the evidence submitted under clause 7i7 is sufficient to demonstrate that the drug meets the requirements described in subclauses 7,i7 through 7,,vi7 of such clause1 not later than ,december #ca1 #bjah1 the ,secretary shall issue a revised label approval for the antimicrobial drug1 as necessary2 or 7,,ii7 if the ,secretary determines that the evidence submitted under clause 7i7 is insufficient to demonstrate that the drug meets the requirements described in subclauses 7,i7 through 7,,vi7 of such clause1 not later than ,december #ca1 #bjah1 the ,secretary shall withdraw approval of any indication claims described in paragraph 7#a77;,c7 for which the ,secretary determines the evidence is insufficient and1 as necessary1 issue a revised label approval4 7,b7 ,withdrawal of claims ,on or before ,january #a1 #bjah1 the sponsor of a drug described in paragraph 7#a7 may request the approval of the ,secretary to remove any label claim described in paragraph 7#a77;,c71 and the ,secretary shall approve any such request and1 as necessary1 issue a revised label4 ,the sponsor shall not be required to submit the evidence required under subparagraph 7,a77i7 with respect to any claim so withdrawn4 7#c7 ,exemptions ,in the case of a drug that is a medically important antimicrobial for which the ,secretary grants an exemption under section #eje7;i71 the withdrawal of indication claims in a food-producing animal in accordance with paragraph 7#b77;,b7 shall be effective on the date that is #b years after the date on which the ,secretary grants the exemption1 unless1 not later than #b years after the date on which the ,secretary grants the exemption1 the ,secretary provides a written determination of intent to extend the exemption4 7#d7 ,definition ,in this subsection1 the term medically important antimicrobial means a drug that-- 7,a7 is intended for use in food-producing animals2 and 7,b7 is composed wholly or partly of-- 7i7 any kind of penicillin1 tetracycline1 macrolide1 lincosamide1 streptogramin1 aminoglycoside1 sulfonamide1 cephalosporin1 or fluoroquinolone2 or 7ii7 a drug from an antimicrobial class that is listed as highly important1 critically important1 or important by the ,world ,health ,organization in the latest edition of its publication entitled ,critically ,important ,antimicrobials for ,human ,medicine 7or a successor publication74 4 #d4 ,sense of the ,senate regarding veterinary oversight of use of medically important antimicrobials 7a7 ,in general ,it is the sense of the ,senate that a valid veterinarian-client-patient relationship should exist to ensure that medically important antimicrobials are used in food-producing animals in a manner that is consistent with professionally accepted best practices4 7b7 ,veterinarian-,client-,patient relationship ,in this section1 the term veterinarian-client-patient relationship means a relationship in which all of the following criteria are met3 7#a7 ,the veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient and the client has agreed to follow the veterinarian's instructions4 7#b7 ,the veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient4 ,this means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of-- 7,a7 a timely examination of the patient by the veterinarian2 or 7,b7 medically appropriate and timely visits by the veterinarian to the premises where the animal or animals are kept4 7#c7 ,the veterinarian is readily available for follow-up evaluation or has arranged for veterinary emergency coverage and continuing care and treatment4 7#d7 ,the veterinarian provides oversight of treatment1 compliance1 and outcome4 7#e7 ,patient records are maintained4