II 

113TH CONGRESS 

1ST SESSION S. 895 

To improve the ability of the Food and Drug Administration to study the 

use of antimicrobial drugs in food-producing animals. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Antimicrobial Data 

5 Collection Act’’. 

6 SEC. 2. RESEARCH PROGRAMS TO STUDY ANTIMICROBIAL 

7 RESISTANCE. 

8 (a) DEFINITIONS.—In this Act— 


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1 (1) the term ‘‘Commissioner’’ means the Com2 missioner of Food and Drugs; and 

3 (2) the term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services. 

5 (b) COMMENCEMENT OF PILOT DATA COLLECTION

6 AND ANALYSIS PROGRAM.—The Secretary, acting through 

7 the Commissioner, shall develop a research program or 

8 programs to study the relationship between the sales, dis9 tribution, end-use practices of animal drugs containing an 

10 antimicrobial active ingredient in food-producing animals 

11 and antimicrobial resistance trends. The Secretary may 

12 also consider any other available sound information, 

13 science, research, expertise, or program designs in car14 rying out this subsection. 

15 (c) PURPOSE OF PROGRAMS.—Any research program 

16 developed under subsection (b) shall be developed in order 

17 to better determine— 

18 (1) the relationships between sales data, dis19 tribution data, and end-usage data of animal drugs 

20 containing an antimicrobial active ingredient in food21 producing animals to inform policies of Food and 

22 Drug Administration regarding data collection and 

23 regulation of antimicrobial products in agriculture, 

24 including consideration of the potential value and 


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1 feasibility of data from veterinary feed directives and 

2 other sources; and 

3 (2) the relationships between the use of animal 

4 drugs containing an antimicrobial active ingredient 

5 in food-producing animals and trends in anti6 microbial resistance, including by using the data col7 lected through the National Antimicrobial Resistance 

8 Monitoring System or other studies regarding resist9 ance levels in bacteria associated with food-pro10 ducing animals. 

11 (d) CONSULTATION.—Any research program devel12 oped under subsection (b) shall be developed in consulta13 tion with the Secretary of Agriculture, which shall include 

14 at a minimum consultation with the Under Secretary for 

15 Food Safety, the Under Secretary for Marketing and Reg16 ulatory Programs, and the Under Secretary for Research, 

17 Education, and Economics at the Department of Agri18 culture. To the extent practicable, such Under Secretaries 

19 shall provide assistance in developing and conducting such 

20 research programs. 

21 (e) IMPLEMENTATION.—Not later than 180 days 

22 after the date of enactment of this Act, the Secretary shall 

23 implement the research program or programs developed 

24 under subsection (b). The Secretary shall analyze data 

25 from such program or programs to determine the conVerDate Mar 15 2010 00:19 May 10, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S895.IS S895

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1 tribution of such data to studying antimicrobial resistance 

2 and establishing the antimicrobial data collection strategy 

3 as described in section 3(b)(1)(B). 

4 SEC. 3. REPORTS TO CONGRESS; DEVELOPMENT OF DATA 

5 COLLECTION STRATEGY. 

6 (a) INITIAL REPORT.—As soon as practicable after 

7 the date of enactment of this Act, the Secretary shall— 

8 (1) submit to Congress a report that— 

9 (A) describes the research design and goals 

10 for the research program or programs developed 

11 under section 2(b); and 

12 (B) includes a needs assessment, consid13 ering broad sources of data and models on anti14 microbial use in food-producing animals that 

15 the Food and Drug Administration may need or 

16 from which the Food and Drug Administration 

17 could benefit, to improve the evaluation of Food 

18 and Drug Administration programs regarding 

19 antimicrobial resistance and how a systematic 

20 and valid data collection strategy will be de21 signed to comply with subsection (b)(1)(B); and 

22 (2) make such report publicly available. 

23 (b) REPORT REGARDING RESULTS AND REC24 OMMENDATIONS.—Not later than 2 years after the date 

25 of enactment of this Act, the Secretary shall— 


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1 (1) submit to Congress a report that— 

2 (A) describes the comprehensive results of 

3 any research program or programs developed 

4 under section 2(b), including with respect to the 

5 determinations made pursuant to paragraphs 

6 (1) and (2) of section 2(c); and 

7 (B) provides recommendations for devel8 oping an antimicrobial data collection strategy 

9 based on the information contained in the com10 ments to the Advanced Notice of Proposed 

11 Rulemaking entitled ‘‘Antimicrobial Animal 

12 Drug Distribution Reporting’’ (77 Fed. Reg. 

13 44177 (July 27, 2012)) and any relevant infor14 mation obtained in the research pilot program 

15 carried out under section 2; and 

16 (2) make such report publicly available. 

17 SEC. 4. ENHANCED REPORTING AND PUBLICATION OF 

18 SALES DATA. 

19 (a) IN GENERAL.—Section 512(l)(3)(E) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 360b(l)(3)(E)) is amended— 

22 (1) by redesignating clauses (i) and (ii) as sub23 clauses (I) and (II); 

24 (2) by striking ‘‘The Secretary shall make sum25 maries of the information reported under this paraVerDate Mar 15 2010 00:19 May 10, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S895.IS S895

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1 graph publicly available, except that—’’ and insert2 ing ‘‘(i) Not later than a date established by the 

3 Secretary for 2014, and on such date in each year 

4 thereafter, the Secretary shall make publicly avail5 able a summary of the information (including dosage 

6 form information, if practicable) reported under this 

7 paragraph for the previous year, except that—’’; and 

8 (3) by inserting after subclause (II), as redesig9 nated by paragraph (1), the following: 

10 ‘‘(ii) In making the summaries available under this 

11 subparagraph, the following shall apply: 

12 ‘‘(I) The Secretary shall segregate the cat13 egories of amounts reported into the following 2 sub14 categories, after consultation with applicable classi15 fications as determined by the Secretary, subject to 

16 subclause (IV): 

17 ‘‘(aa) The volume of drugs of importance 

18 to human medicine. 

19 ‘‘(bb) The volume of drugs not of impor20 tance to human medicine. 

21 ‘‘(II) As practicable, the Secretary shall seg22 regate amounts reported into the following: 

23 ‘‘(aa) Container size. 

24 ‘‘(bb) Strength. 

25 ‘‘(cc) Dosage form. 


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1 ‘‘(dd) Marketing status. 

2 ‘‘(III) In any cross-tabulation of the amounts 

3 reported with any reporting category, the Secretary 

4 shall include the categories ‘Not Independently Re5 ported’ and ‘Not Independently Reported Export’. 

6 ‘‘(IV) Every 5 years, the Secretary shall re7 evaluate the classifications consulted under sub8 clause (I) after opportunity for public comment. 

9 ‘‘(iii) The Secretary shall maximize the quality, accu10 racy, detail, and specificity of data made publicly available 

11 in the summaries under this subparagraph, to the extent 

12 practicable, such as regarding the type, estimated level of 

13 exposure, and target animals of antimicrobial drugs. In 

14 carrying out the preceding sentence, the Secretary may 

15 provide additional information in such summaries. 

16 ‘‘(iv) The Secretary shall conduct an annual evalua17 tion of the effectiveness of and compliance with relevant 

18 policies and programs of the Food and Drug Administra19 tion regarding antimicrobial drug sales for food-producing 

20 animals, and use of such drugs and antimicrobial resist21 ance, using valid and robust performance metrics. Begin22 ning in 2014, the Secretary shall include with each annual 

23 summary made publicly available under this subparagraph 

24 a report that describes the results of the evaluation conVerDate Mar 15 2010 00:19 May 10, 2013 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S895.IS S895

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1 ducted under this clause with respect to the preceding 

2 year.’’. 

3 (b) REISSUANCE.—Not later than 3 years after the 

4 date of enactment of this Act, the Secretary shall reissue 

5 the summary reports issued before 2012 under section 

6 512(l)(3)(E) of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 360b(l)(3)(E)) using the format designed for 

8 the 2012 summary report. The Secretary shall publish the 

9 reissued reports in one combined publication. 

10 SEC. 5. ACTION TO PROTECT PUBLIC AND ANIMAL HEALTH. 

11 (a) PUBLICATION OF FINAL GUIDANCE.— 

12 (1) IN GENERAL.—Not later than 180 days 

13 after the date of enactment of this Act, the Sec14 retary shall publish a final version of the draft Vol15 untary Guidance #213 of the Food and Drug Ad16 ministration (entitled ‘‘New Animal Drugs and New 

17 Animal Drug Combination Products Administered in 

18 or on Medicated Feed or Drinking Water of Food19 Producing Animals: Recommendations for Drug 

20 Sponsors for Voluntarily Aligning Product Use Con21 ditions with GFI #209’’). 

22 (2) EFFECT OF SUBSECTION.—Nothing in this 

23 subsection shall be construed to affect any other ob24 ligations of the Food and Drug Administration re25 garding the authorities of such Administration to 


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1 regulate antimicrobial drugs and protect public 

2 health. 

3 (b) REPORT BY GAO.— 

4 (1) IN GENERAL.—Not later than 3 years after 

5 the conclusion of the research pilot program or pro6 grams developed under section 2, the Comptroller 

7 General of the United States shall commence a 

8 study to evaluate— 

9 (A) the approaches used by the Food and 

10 Drug Administration to eliminate injudicious 

11 use of antimicrobial drugs in food-producing 

12 animals; and 

13 (B) the effectiveness of the data collection 

14 activities carried out by the Food and Drug Ad15 ministration regarding antimicrobial resistance. 

16 (2) REPORT.—Not later than 1 year after com17 mencing the study described in paragraph (1), the 

18 Comptroller General of the United States shall sub19 mit to the Committee on Health, Education, Labor, 

20 and Pensions of the Senate and the Committee on 

21 Energy and Commerce of the House of Representa22 tives a report that describes the results of such 

23 study. 

Æ 


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