Don't show this message again
21 U.S. Code § 360ccc. Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
(a) Application requirements
(1)
(A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of—
(i)
a new animal drug intended for a minor use or a minor species; or
(ii) a new animal drug not intended for a minor use or minor species—
(I)
that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and
(II)
for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.
(B)
The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii).
(C)
An application under this paragraph shall comply in all respects with the provisions of section 360b of this title except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section.
(D)
New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section 360b(d) of this title (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).
(2) The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug—
(A)
all information necessary to meet the requirements of section 360b(b)(1) of this title except section 360b(b)(1)(A) of this title;
(B)
full reports of investigations which have been made to show whether or not such drug is safe under section 360b(d) of this title (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance) and there is a reasonable expectation of effectiveness for use;
(C)
data for establishing a conditional dose;
(D)
projections of expected need and the justification for that expectation based on the best information available;
(E)
information regarding the quantity of drug expected to be distributed on an annual basis to meet the expected need; and
(F)
a commitment that the applicant will conduct additional investigations to meet the requirements for the full demonstration of effectiveness under section 360b(d)(1)(E) of this title within 5 years.
(3)
(A) A person may not file an application under paragraph (1) if—
(i)
the application seeks conditional approval of a new animal drug that is contained in, or is a product of, a transgenic animal.[1]
(ii)
the person has previously filed an application for conditional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b); or
(iii)
the person obtained the application, or data or other information contained therein, directly or indirectly from the person who filed for conditional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b).
(B)
A person may not file an application under paragraph (1)(A)(ii) if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient.