,,ii #aacth ,,congress #ast ,session ,s4 #hie ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #h1 #bjac ,mrs4 ,gillibrand 7for herself1 ,mrs4 ,feinstein1 and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve the ability of the ,food and ,drug ,administration to study the use of antimicrobial drugs in food-producing animals4 #a4 ,short title ,this ,act may be cited as the ,antimicrobial ,data ,collection ,act4 #b4 ,research programs to study antimicrobial resistance 7a7 ,definitions ,in this ,act-- 7#a7 the term ,commissioner means the ,commissioner of ,food and ,drugs2 and 7#b7 the term ,secretary means the ,secretary of ,health and ,human ,services4 7b7 ,commencement of pilot data collection and analysis program ,the ,secretary1 acting through the ,commissioner1 shall develop a research program or programs to study the relationship between the sales1 distribution1 end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends4 ,the ,secretary may also consider any other available sound information1 science1 research1 expertise1 or program designs in carrying out this subsection4 7c7 ,purpose of programs ,any research program developed under subsection 7b7 shall be developed in order to better determine-- 7#a7 the relationships between sales data1 distribution data1 and end-usage data of animal drugs containing an antimicrobial active ingredient in food-producing animals to inform policies of ,food and ,drug ,administration regarding data collection and regulation of antimicrobial products in agriculture1 including consideration of the potential value and feasibility of data from veterinary feed directives and other sources2 and 7#b7 the relationships between the use of animal drugs containing an antimicrobial active ingredient in food-producing animals and trends in antimicrobial resistance1 including by using the data collected through the ,national ,antimicrobial ,resistance ,monitoring ,system or other studies regarding resistance levels in bacteria associated with food-producing animals4 7d7 ,consultation ,any research program developed under subsection 7b7 shall be developed in consultation with the ,secretary of ,agriculture1 which shall include at a minimum consultation with the ,under ,secretary for ,food ,safety1 the ,under ,secretary for ,marketing and ,regulatory ,programs1 and the ,under ,secretary for ,research1 ,education1 and ,economics at the ,department of ,agriculture4 ,to the extent practicable1 such ,under ,secretaries shall provide assistance in developing and conducting such research programs4 7e7 ,implementation ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall implement the research program or programs developed under subsection 7b74 ,the ,secretary shall analyze data from such program or programs to determine the contribution of such data to studying antimicrobial resistance and establishing the antimicrobial data collection strategy as described in section #c7;b77#a77;,b74 #c4 ,reports to ,congress2 development of data collection strategy 7a7 ,initial report ,as soon as practicable after the date of enactment of this ,act1 the ,secretary shall-- 7#a7 submit to ,congress a report that-- 7,a7 describes the research design and goals for the research program or programs developed under section #b7;b72 and 7,b7 includes a needs assessment1 considering broad sources of data and models on antimicrobial use in food-producing animals that the ,food and ,drug ,administration may need or from which the ,food and ,drug ,administration could benefit1 to improve the evaluation of ,food and ,drug ,administration programs regarding antimicrobial resistance and how a systematic and valid data collection strategy will be designed to comply with subsection 7b77#a77;,b72 and 7#b7 make such report publicly available4 7b7 ,report regarding results and recommendations ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall-- 7#a7 submit to ,congress a report that-- 7,a7 describes the comprehensive results of any research program or programs developed under section #b7;b71 including with respect to the determinations made pursuant to paragraphs 7#a7 and 7#b7 of section #b7;c72 and 7,b7 provides recommendations for developing an antimicrobial data collection strategy based on the information contained in the comments to the ,advanced ,notice of ,proposed ,rulemaking entitled ,antimicrobial ,animal ,drug ,distribution ,reporting 7#gg ,fed4 ,reg4 #ddagg 7,july #bg1 #bjab77 and any relevant information obtained in the research pilot program carried out under section #b2 and 7#b7 make such report publicly available4 #d4 ,enhanced reporting and publication of sales data 7a7 ,in general ,section #eab7l77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7l77#c77;,e77 is amended-- 7#a7 by redesignating clauses 7i7 and 7ii7 as subclauses 7,i7 and 7,,ii72 7#b7 by striking ,the ,secretary shall make summaries of the information reported under this paragraph publicly available1 except that-- and inserting 7i7 ,not later than a date established by the ,secretary for #bjad1 and on such date in each year thereafter1 the ,secretary shall make publicly available a summary of the information 7including dosage form information1 if practicable7 reported under this paragraph for the previous year1 except that--2 and 7#c7 by inserting after subclause 7,,ii71 as redesignated by paragraph 7#a71 the following3 7ii7 ,in making the summaries available under this subparagraph1 the following shall apply3 7,i7 ,the ,secretary shall segregate the categories of amounts reported into the following #b subcategories1 after consultation with applicable classifications as determined by the ,secretary1 subject to subclause 7,,iv73 7aa7 ,the volume of drugs of importance to human medicine4 7bb7 ,the volume of drugs not of importance to human medicine4 7,,ii7 ,as practicable1 the ,secretary shall segregate amounts reported into the following3 7aa7 ,container size4 7bb7 ,strength4 7cc7 ,dosage form4 7dd7 ,marketing status4 7,,iii7 ,in any cross-tabulation of the amounts reported with any reporting category1 the ,secretary shall include the categories ,not ,independently ,reported and ,not ,independently ,reported ,export4 7,,iv7 ,every #e years1 the ,secretary shall reevaluate the classifications consulted under subclause 7,i7 after opportunity for public comment4 7iii7 ,the ,secretary shall maximize the quality1 accuracy1 detail1 and specificity of data made publicly available in the summaries under this subparagraph1 to the extent practicable1 such as regarding the type1 estimated level of exposure1 and target animals of antimicrobial drugs4 ,in carrying out the preceding sentence1 the ,secretary may provide additional information in such summaries4 7iv7 ,the ,secretary shall conduct an annual evaluation of the effectiveness of and compliance with relevant policies and programs of the ,food and ,drug ,administration regarding antimicrobial drug sales for food-producing animals1 and use of such drugs and antimicrobial resistance1 using valid and robust performance metrics4 ,beginning in #bjad1 the ,secretary shall include with each annual summary made publicly available under this subparagraph a report that describes the results of the evaluation conducted under this clause with respect to the preceding year4 4 7b7 ,reissuance ,not later than #c years after the date of enactment of this ,act1 the ,secretary shall reissue the summary reports issued before #bjab under section #eab7l77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7l77#c77;,e77 using the format designed for the #bjab summary report4 ,the ,secretary shall publish the reissued reports in one combined publication4 #e4 ,action to protect public and animal health 7a7 ,publication of final guidance 7#a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary shall publish a final version of the draft ,voluntary ,guidance #bac of the ,food and ,drug ,administration 7entitled ,new ,animal ,drugs and ,new ,animal ,drug ,combination ,products ,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 #bji74 7#b7 ,effect of subsection ,nothing in this subsection shall be construed to affect any other obligations of the ,food and ,drug ,administration regarding the authorities of such ,administration to regulate antimicrobial drugs and protect public health4 7b7 ,report by ,,gao 7#a7 ,in general ,not later than #c years after the conclusion of the research pilot program or programs developed under section #b1 the ,comptroller ,general of the ,united ,states shall commence a study to evaluate-- 7,a7 the approaches used by the ,food and ,drug ,administration to eliminate injudicious use of antimicrobial drugs in food-producing animals2 and 7,b7 the effectiveness of the data collection activities carried out by the ,food and ,drug ,administration regarding antimicrobial resistance4 7#b7 ,report ,not later than #a year after commencing the study described in paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that describes the results of such study4