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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.
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.