S.Amdt. 2007

1. Adds TITLE III--USE OF ANTIMICROBIAL DRUGS IN FOOD ANIMALS at the end of the bill

   Adds a title

   In H.R. 3204 · Engrossed in House

   Passed the House of Representatives September 28, 2013.

   Inserted: TITLE III--USE OF ANTIMICROBIAL DRUGS IN FOOD ANIMALS

   Inserted: SEC. 301. SHORT TITLE.

   Inserted: This title may be cited as the "Delivering Antimicrobial Transparency in Animals Act of 2013".

   Inserted: SEC. 302. PURPOSE.

   Inserted: The purpose of this title is to provide the Food and Drug Administration and the public with better information on the use of antimicrobial drugs in animals used for food to--

   Inserted: (1) enable public health officials and scientists to better understand and interpret trends and variations in rates of microbial resistance to such antimicrobial drugs;

   Inserted: (2) improve the understanding of the relationship between antimicrobial drug use in animals used for food and antimicrobial drug resistance in microbes in and on animals and humans; and

   Inserted: (3) identify interventions to prevent and control such antimicrobial drug resistance.

   Inserted: SEC. 303. RESEARCH PROGRAMS TO STUDY ANTIMICROBIAL RESISTANCE.

   Inserted: (a) Definitions.--In this title--

   Inserted: (1) the term "Commissioner" means the Commissioner of Food and Drugs; and

   Inserted: (2) the term "Secretary" means the Secretary of Health and Human Services.

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   Inserted: (b) Establishment of Programs.--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.

   Inserted: (c) Purpose of Programs.--Any research program developed under subsection (b) shall be developed in order to better determine--

   Inserted: (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 of data from veterinary feed directives; and

   Inserted: (2) the relationships between antimicrobial resistance and 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 Program or other studies regarding resistance levels in bacteria associated with food-producing animals.

   Inserted: (d) Consultation.--Any research program developed under subsection (b) shall be developed in 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.

   Inserted: (e) Implementation.--Not later than 1 year 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, protecting public health, and establishing the coordinated data collection strategy as described in section 305.

   Inserted: (f) Publication.--The Secretary shall publish the results of any research program developed under this section as soon as practicable.

   Inserted: SEC. 304. ENHANCED REPORTING AND PUBLICATION OF SALES DATA.

   Inserted: (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--

   Inserted: (1) by redesignating clauses (i) and (ii) as subclauses (I) and (II);

   Inserted: (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

   Inserted: (3) by inserting after subclause (II), as redesignated by paragraph (1), the following:

   Inserted: "(ii) In making the summaries available under this subparagraph, the following shall apply:

   Inserted: "(I) The Secretary shall segregate the categories of amounts reported into the following 2 subcategories, after consultation with the applicable classifications of the World Health Organization:

   Inserted: "(aa) The volume of drugs of importance to human medicine.

   Inserted: "(bb) The volume of drugs not of importance to human medicine.

   Inserted: "(II) As practicable, the Secretary shall segregate amounts reported into the following 2 amounts:

   Inserted: "(aa) The volume of drugs labeled or eligible for use in food-producing animals.

   Inserted: "(bb) The volume of drugs that are not labeled or are ineligible for use in food-producing animals.

   Inserted: "(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'.".

   Inserted: (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.

   Inserted: SEC. 305. IMPLEMENTATION AND PUBLICATION OF ANTIMICROBIAL RESISTANCE DATA COLLECTION STRATEGY.

   Inserted: (a) In General.--Not later than 3 years after the date of enactment of this Act, the Secretary, acting through the Commissioner, shall implement an Antimicrobial Data Collection Strategy, based on information received 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 research program developed under section 303.

   Inserted: (b) Reevaluation.--Not less than every 5 years after the implementation of the Antimicrobial Data Collection Strategy under subsection (a), the Secretary shall reevaluate such Strategy and propose modifications as such Secretary determines appropriate, based on scientific data.

   Inserted: (c) Availability.--The Secretary shall--

   Inserted: (1) submit to Congress the Strategy implemented under subsection (a), and any modification made to such Strategy pursuant to subsection (b); and

   Inserted: (2) make such Strategy and any such modification available to the public.

   Inserted: SEC. 306. ACTION BY GOVERNMENT ACCOUNTABILITY OFFICE.

   Inserted: (a) Publication of Final Guidance.--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").

   Inserted: (b) Report by GAO.--

   Inserted: (1) In general.--Not later than 3 years after the publication of the final guidance described in subsection (a), the Comptroller General of the United States shall commence a study to evaluate--

   Inserted: (A) the voluntary approach used by the Food and Drug Administration to eliminate injudicious use of antimicrobial drugs in food-producing animals; and

   Inserted: (B) the effectiveness of the data collection activities conducted by the Food and Drug Administration regarding antimicrobial resistance.

   Inserted: (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.

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