section (b)’’ and inserting ‘‘subsection (b) or section 
571’’ and by inserting ‘‘or upon failure to renew a 
conditional approval under section 571’’ after ‘‘or 
upon its suspension’’. 
(15) Section 512(l)(1) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘subsection (b)’’ and inserting ‘‘subsection (b) or 
section 571’’. 
(16) Section 512(m)(1)(C) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking ‘‘ap-
plicable regulations published pursuant to subsection 
(i)’’ and inserting ‘‘applicable regulations published 
pursuant to subsection (i) or for indexed new animal 
drugs in accordance with the index listing published 
pursuant to section 572(e)(2) and the labeling re-
quirements set forth in section 572(h)’’. 
(17) Section 512(m)(3) of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting ‘‘or 
an index listing pursuant to section 572(e)’’ after 
‘‘subsection (i)’’ each place it appears. 
(18) Section 512(p)(1) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) 
or section 571(a)’’.
(19) Section 512(p)(2) of the Federal Food, 
Drug, and Cosmetic Act is amended by striking 
‘‘subsection (b)(1)’’ and inserting ‘‘subsection (b)(1) 
or section 571(a)’’. 
(20) Section 108(b)(3) of Public Law 90–399 is 
amended by striking ‘‘section 201(w) as added by 
this Act’’ and inserting ‘‘section 201(v) as added by 
the Minor Use and Minor Species Animal Health 
Act of 2003’’. 
(h) REGULATIONS.—The Secretary of Health and 
Human Services shall implement sections 571 and 573 of 
the Federal Food, Drug, and Cosmetic Act and subse-
quently publish implementing regulations. Not later than 
12 months after the date of enactment of this Act, the 
Secretary shall issue proposed regulations to implement 
section 573 of the Federal Food, Drug, and Cosmetic Act 
(as added by this Act), and not later than 24 months after 
the date of enactment of this Act, the Secretary shall issue 
final regulations implementing section 573 of the Federal 
Food, Drug, and Cosmetic Act. Not later than 18 months 
after the date of enactment of this Act, the Secretary shall 
issue proposed regulations to implement section 572 of the 
Federal Food, Drug, and Cosmetic Act (as added by this 
Act), and not later than 36 months after the date of enact-
ment of this Act, the Secretary shall issue final regulations
implementing section 572 of the Federal Food, Drug, and 
Cosmetic Act. Not later than 30 months after the date 
of enactment of this Act, the Secretary shall issue pro-
posed regulations to implement section 571 of the Federal 
Food, Drug, and Cosmetic Act (as added by this Act), and 
not later than 42 months after the date of enactment of 
this Act, the Secretary shall issue final regulations imple-
menting section 571 of the Federal Food, Drug, and Cos-
metic Act. These timeframes shall be extended by 12 
months for each fiscal year, in which the funds authorized 
to be appropriated under subsection (i) are not in fact ap-
propriated. 
(i) OFFICE.—The Secretary of Health and Human 
Services shall establish within the Center for Veterinary 
Medicine (of the Food and Drug Administration), an Of-
fice of Minor Use and Minor Species Animal Drug Devel-
opment that reports directly to the Director of the Center 
for Veterinary Medicine. This office shall be responsible 
for overseeing the development and legal marketing of new 
animal drugs for minor uses and minor species. There is 
authorized to be appropriated to carry out this subsection 
$1,200,000 for fiscal year 2003 and such sums as may 
be necessary for each fiscal year thereafter. 
(j) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out section 573(b)
of the Federal Food, Drug, and Cosmetic Act (as added 
by this Act) $1,000,000 for the fiscal year following publi-
cation of final implementing regulations, $2,000,000 for 
the subsequent fiscal year, and such sums as may be nec-
essary for each fiscal year thereafter.
Æ