Antimicrobial Data Collection Act

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Antimicrobial Data Collection Act''.

SEC. 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).

SEC. 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.

SEC. 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.

SEC. 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.

Summary: Antimicrobial Data Collection Act - Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to develop a research program to study the relationship between the sales, distribution, and end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. Requires the Secretary to analyze data from the program to determine the data's contribution to studying antimicrobial resistance and establishing an antimicrobial data collection strategy. Requires the Secretary to: (1) report to Congress on the program's research design and goals, including a needs assessment to improve the FDA's evaluation of antimicrobial resistance. And (2) report to Congress and the public within two years with the comprehensive results of the program and recommendations for developing an antimicrobial data collection strategy. Amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for the annual summaries of antimicrobial animal drug information, including by requiring the Secretary to maximize the quality, accuracy, detail, and specificity of the data made publicly available in the summaries. Requires the Secretary to conduct an annual evaluation of the effectiveness of and compliance with relevant FDA programs and policies regarding antimicrobial drug sales for food-producing animals, and the use of such drugs and antimicrobial resistance. Directs the Secretary to publish a final version of voluntary guidance for drug sponsors on new animal drugs and new animal drug combination products administered in or on medicated feed or drinking water of food-producing animals. Requires the Comptroller General (GAO) to evaluate the FDA's approaches to eliminate injudicious use of antimicrobial drugs in food-producing animals and the effectiveness of the FDA's data collection activities regarding antimicrobial resistance.