II 113th CONGRESS 1st Session S. 895 IN THE SENATE OF THE UNITED STATES May 8, 2013 Mrs. Gillibrand (for herself, Mrs. Feinstein , and Ms. Collins ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To improve the ability of the Food and Drug Administration to study the use of antimicrobial drugs in food-producing animals.

1. Short title This Act may be cited as the Antimicrobial Data Collection Act . 2. Research programs to study antimicrobial resistance (a) Definitions In this Act— (1) the term Commissioner means the Commissioner of Food and Drugs; and (2) the term Secretary means the Secretary of Health and Human Services. (b) Commencement of pilot data collection and analysis program The Secretary, acting through the Commissioner, shall develop a research program or programs to study the relationship between the sales, distribution, end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. The Secretary may also consider any other available sound information, science, research, expertise, or program designs in carrying out this subsection. (c) Purpose of programs Any research program developed under subsection (b) shall be developed in order to better determine— (1) the relationships between sales data, distribution data, 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 agriculture, including consideration of the potential value and feasibility of data from veterinary feed directives and other sources; and (2) the relationships between the use of animal drugs containing an antimicrobial active ingredient in food-producing animals and trends in antimicrobial resistance, 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 animals. (d) Consultation Any research program developed under subsection (b) shall be developed in consultation with the Secretary of Agriculture, which shall include at a minimum consultation with the Under Secretary for Food Safety, the Under Secretary for Marketing and Regulatory Programs, and the Under Secretary for Research, Education, and Economics at the Department of Agriculture. To the extent practicable, such Under Secretaries shall provide assistance in developing and conducting such research programs. (e) Implementation Not later than 180 days after the date of enactment of this Act, the Secretary shall implement the research program or programs developed under subsection (b). 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 3(b)(1)(B). 3. Reports to Congress; development of data collection strategy (a) Initial report As soon as practicable after the date of enactment of this Act, the Secretary shall— (1) submit to Congress a report that— (A) describes the research design and goals for the research program or programs developed under section 2(b); and (B) includes a needs assessment, 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 benefit, 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 (b)(1)(B); and (2) make such report publicly available. (b) Report regarding results and recommendations Not later than 2 years after the date of enactment of this Act, the Secretary shall— (1) submit to Congress a report that— (A) describes the comprehensive results of any research program or programs developed under section 2(b), including with respect to the determinations made pursuant to paragraphs (1) and (2) of section 2(c); and (B) 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 (77 Fed. Reg. 44177 (July 27, 2012)) and any relevant information obtained in the research pilot program carried out under section 2; and (2) make such report publicly available. 4. Enhanced reporting and publication of sales data (a) In general Section 512(l)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b(l)(3)(E) ) is amended— (1) by redesignating clauses (i) and (ii) as subclauses (I) and (II); (2) by striking The Secretary shall make summaries of the information reported under this paragraph publicly available, except that— and inserting (i) Not later than a date established by the Secretary for 2014, and on such date in each year thereafter, the Secretary shall make publicly available a summary of the information (including dosage form information, if practicable) reported under this paragraph for the previous year, except that— ; and (3) by inserting after subclause (II), as redesignated by paragraph (1), the following: (ii) In making the summaries available under this subparagraph, the following shall apply: (I) The Secretary shall segregate the categories of amounts reported into the following 2 subcategories, after consultation with applicable classifications as determined by the Secretary, subject to subclause (IV): (aa) The volume of drugs of importance to human medicine. (bb) The volume of drugs not of importance to human medicine. (II) As practicable, the Secretary shall segregate amounts reported into the following: (aa) Container size. (bb) Strength. (cc) Dosage form. (dd) Marketing status. (III) In any cross-tabulation of the amounts reported with any reporting category, the Secretary shall include the categories Not Independently Reported and Not Independently Reported Export . (IV) Every 5 years, the Secretary shall reevaluate the classifications consulted under subclause (I) after opportunity for public comment. (iii) The Secretary shall maximize the quality, accuracy, detail, and specificity of data made publicly available in the summaries under this subparagraph, to the extent practicable, such as regarding the type, estimated level of exposure, and target animals of antimicrobial drugs. In carrying out the preceding sentence, the Secretary may provide additional information in such summaries. (iv) 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 animals, and use of such drugs and antimicrobial resistance, using valid and robust performance metrics. Beginning in 2014, 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 year. . (b) Reissuance Not later than 3 years after the date of enactment of this Act, the Secretary shall reissue the summary reports issued before 2012 under section 512(l)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b(l)(3)(E) ) using the format designed for the 2012 summary report. The Secretary shall publish the reissued reports in one combined publication. 5. Action to protect public and animal health (a) Publication of final guidance (1) In general Not later than 180 days after the date of enactment of this Act, the Secretary shall publish a final version of the draft Voluntary Guidance #213 of the Food and Drug Administration (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 GFI #209 ). (2) 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 health. (b) Report by GAO (1) In general Not later than 3 years after the conclusion of the research pilot program or programs developed under section 2, the Comptroller General of the United States shall commence a study to evaluate— (A) the approaches used by the Food and Drug Administration to eliminate injudicious use of antimicrobial drugs in food-producing animals; and (B) the effectiveness of the data collection activities carried out by the Food and Drug Administration regarding antimicrobial resistance. (2) Report Not later than 1 year after commencing the study described in paragraph (1), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, 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 study.