antimicrobial animal drug, the Secretary shall re-
scind each approval of a nontherapeutic use in a 
food-producing animal of the critical antimicrobial 
animal drug, or of a drug in the same chemical class 
as the critical antimicrobial animal drug, as of the 
date that is 2 years after the date on which the Sec-
retary grants the exemption. 
‘‘(4) APPROVALS.—Except as provided in para-
graph (5), if an application for a drug that is a crit-
ical antimicrobial animal drug is submitted to the 
Secretary under section 505(b), the Secretary shall 
rescind each approval of a nontherapeutic use in a 
food-producing animal of the critical antimicrobial 
animal drug, or of a drug in the same chemical class 
as the critical antimicrobial animal drug, as of the 
date that is 2 years after the date on which the ap-
plication is submitted to the Secretary. 
‘‘(5) EXCEPTION.—Paragraph (3) or (4), as the 
case may be, shall not apply if—
‘‘(A) before the date on which approval 
would be rescinded under that paragraph, the 
Secretary makes a final written determination 
that the holder of the application for the ap-
proved nontherapeutic use has demonstrated 
that there is a reasonable certainty of no harm
to human health due to the development of 
antimicrobial resistance that is attributable in 
whole or in part to the nontherapeutic use in 
the food-producing animal of the critical anti-
microbial animal drug; or 
‘‘(B) before the date specified in subpara-
graph (A), the Secretary makes a final written 
determination under this subsection, with re-
spect to a risk analysis of the critical anti-
microbial animal drug conducted by the Sec-
retary and any other relevant information, that 
there is a reasonable certainty of no harm to 
human health due to the development of anti-
microbial resistance that is attributable in 
whole or in part to the nontherapeutic use of 
the drug.’’. 
TITLE 
II—USE 
OF 
CRITICAL 
ANTIMICROBIAL 
ANIMAL 
DRUGS IN AGRICULTURE 
SEC. 201. COLLECTION OF DATA ON CRITICAL ANTI-
MICROBIAL ANIMAL DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 512 (21 U.S.C. 360b) the following:
‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI-
MICROBIAL ANIMAL DRUGS. 
‘‘(a) IN GENERAL.—Not later than July 1 of each 
year, a manufacturer of a critical antimicrobial animal 
drug or an animal feed for food-producing animals bearing 
or containing a critical antimicrobial animal drug shall 
submit to the Secretary a report, in such form as the Sec-
retary shall require, containing information on the sales 
during the previous calendar year of the critical anti-
microbial animal drug or the animal feed. 
‘‘(b) INFORMATION
TO BE INCLUDED.—A report 
under subsection (a) shall—
‘‘(1) state separately the quantity of the critical 
antimicrobial animal drug, including such quantity 
in animal feed bearing or containing the critical 
antimicrobial drug, sold for each kind of food-pro-
ducing animal; 
‘‘(2) describe the claimed purpose of use for the 
drug for each kind of food-producing animal as 
being for growth promotion, weight gain, feed effi-
ciency, disease prevention, disease control, disease 
treatment, or another purpose; and 
‘‘(3) describe the dosage form of the drug. 
‘‘(c) PUBLICATION.—
‘‘(1) IN GENERAL.—The Secretary shall make 
the information submitted under subsection (a) 
available to the public not less than annually. 
‘‘(2) PROTECTION OF CONFIDENTIALITY.—The 
Secretary may aggregate information, if necessary, 
so as to avoid disclosure under paragraph (1) of con-
fidential business information.’’. 
(b) VIOLATION.—Subsection (e) of section 301 of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 331(e)) 
is amended by striking ‘‘515(f)’’ and inserting ‘‘512A, 
515(f)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on January 1, 2005.
Æ