the amount of each antimicrobial active ingredient in 
the drug that is sold or distributed for use in food- 
producing animals, including information on any dis-
tributor-labeled product. 
‘‘(B) Each report under this paragraph shall 
specify the amount of each antimicrobial active in-
gredient— 
‘‘(i) by container size, strength, and dosage 
form; 
‘‘(ii) by quantities distributed to each State 
domestically and by quantities exported; and 
‘‘(iii) by dosage form, including (for each 
dosage form) the known or estimated amounts 
of the antimicrobial active ingredient sold or 
distributed for use in each food-producing ani-
mal for which the new animal drug is approved, 
including a description of the methods used to 
determine or estimate the amounts. 
‘‘(4)(A) Subject to subparagraph (B), in the 
case of animal feed in final formulation bearing or 
containing a new animal drug for which reporting is 
required under paragraph (3), a live poultry dealer, 
swine contractor, or feed lot operator who purchases, 
contracts, or manufactures such feed shall submit to 
the Secretary an annual report that specifies, by 
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food-producing animal for which the new animal 
drug is approved and, where applicable as deter-
mined by the Secretary, by production class of such 
animal— 
‘‘(i) the amount of each antimicrobial ac-
tive ingredient contained per kilogram of each 
such feed sold or distributed for that animal 
and, where applicable, production class; 
‘‘(ii) the quantity of such feed sold or dis-
tributed for that animal and, where applicable, 
production class; and 
‘‘(iii) for each such feed sold or distributed 
under a veterinary feed directive— 
‘‘(I) the indications for which the feed 
was sold or distributed and the quantities 
of such feed that were sold or distributed 
per each such indication; 
‘‘(II) the number of individuals of the 
food-producing animal and, where applica-
ble, the production class to which the feed 
was intended; and 
‘‘(III) the length of time over which 
the feed was intended to be provided to the 
animals and the dose of the active anti-
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microbial ingredient the animals were in-
tended to receive. 
‘‘(B)(i) Subparagraph (A) does not apply to a 
live poultry dealer, swine contractor, or feed lot op-
erator if the total value of the live animals owned, 
purchased, sold, contracted for, or otherwise con-
trolled by the dealer, contractor, or operator, directly 
or through subsidiaries or affiliates, per year, does 
not exceed— 
‘‘(I) $10,000,000; or 
‘‘(II) such other sum as the Secretary may 
specify through regulation. 
‘‘(ii) The Secretary may specify through regula-
tion alternative reporting requirements, including via 
pilot programs or based on the results of pilot pro-
grams— 
‘‘(I) to improve the accuracy of reports; 
‘‘(II) to lessen the burden of reporting; 
‘‘(III) to facilitate the Secretary’s ability to 
provide public summaries of the reports; or 
‘‘(IV) to improve the Secretary’s ability to 
use the reports, or the public’s ability to use the 
summaries under paragraph (5), to understand 
the relationship between sales, distribution, and 
end-use practices with respect to feed con-
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taining new animal drugs described in para-
graph (1) and antimicrobial resistance trends in 
microbes in animals, animal food products, and 
humans. 
‘‘(5)(A) Each report under paragraph (3) or (4) 
shall— 
‘‘(i) be submitted electronically not later 
than March 31 each year; 
‘‘(ii) cover the period of the preceding cal-
endar year; 
‘‘(iii) include separate information for each 
month of such calendar year; and 
‘‘(iv) be in such format as the Secretary 
may require. 
‘‘(B) In specifying a format under subpara-
graph (A)(iv), the Secretary shall seek to ensure 
that such format enables the data reported to be in-
tegrated or otherwise easily associated and compared 
with data from other Federal databases containing 
data on— 
‘‘(i) drug sales for human use; and 
‘‘(ii) rates of antimicrobial resistance in 
bacteria in and on animals, animal food prod-
ucts, and people. 
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‘‘(C) The Secretary may share information re-
ported under paragraph (3) or (4) with the Anti-
microbial Resistance Task Force established under 
section 319E of the Public Health Service Act. 
‘‘(D)(i) Not later than November 30 each year, 
the Secretary shall make publicly available sum-
maries of the information reported under paragraphs 
(3) and (4). 
‘‘(ii) For each summary under clause (i), except 
as provided in clause (iii), the Secretary shall— 
‘‘(I) report data by antimicrobial drug 
class; 
‘‘(II) for each such antimicrobial drug 
class, specify— 
‘‘(aa) the quantity of drugs sold or 
distributed per dosage form; 
‘‘(bb) the percentage of drugs sold or 
distributed with labeled indications that 
fall within each of the following categories: 
growth promotion, feed efficiency, or other 
production purposes; disease prevention; 
disease control; and disease treatment; 
‘‘(cc) the quantity of drugs sold or 
distributed per each of the following mar-
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keting categories: over-the-counter, pre-
scription, and veterinary feed directive; 
‘‘(dd) the quantity of drugs sold or 
distributed per State of sale or distribu-
tion; and 
‘‘(ee) the known or estimated quantity 
of drugs sold or distributed for each food- 
producing animal and, where feasible, pro-
duction class of such animal; and 
‘‘(III) for each feed sold or distributed 
under a veterinary food directive for which re-
porting is required under paragraph (4), in-
clude the information reported pursuant to sub-
clauses (I), (II), and (III) of paragraph 
(4)(A)(iii). 
‘‘(iii) For any antimicrobial drug class with 
fewer than 3 sponsors of approved new animal 
drugs, instead of reporting data under clause (ii), 
the Secretary shall for each such class— 
‘‘(I) report data by category of importance 
of the antimicrobial drugs within that class to 
human medicine, as determined by the Sec-
retary; and 
‘‘(II) to the extent feasible for each such 
category, specify— 
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