Title: Animal Health and Innovation Act of 2018
Policy area: Health

Summary:
Animal Health and Innovation Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Food and Drug Administration to conditionally approve a new animal drug that (1)	is intended to treat a serious or life-threatening disease or condition or address an unmet animal or human health need, and (2)	a demonstration of effectiveness would require a complex or particularly difficult study or studies.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5599 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 5599

    To amend the Federal Food, Drug, and Cosmetic Act to expand the 
   conditional approval pathway for more animal drugs, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 24, 2018

 Mr. Hudson (for himself, Mr. Schrader, Mr. Bucshon, Mr. Butterfield, 
 and Mr. Mullin) introduced the following bill; which was referred to 
                  the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to expand the 
   conditional approval pathway for more animal drugs, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Animal Health and Innovation Act of 
2018''.

SEC. 2. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS.

    Section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ccc) is amended--
            (1) in the section heading, by striking ``species'' and 
        inserting ``species and certain new animal drugs'';
            (2) in subsection (a)--
                    (A) by amending paragraph (1) to read as follows:
            ``(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 512 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 conditionally approved under this 
        section are subject to application of the same safety standards 
        that would be applied to new animal drugs approved under 
        section 512(d) (including, for antimicrobial new animal drugs, 
        with respect to antimicrobial resistance).''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (A), by striking the 
                        period at the end and inserting ``or a new 
                        animal drug that is an antibiotic drug;''; and
                            (ii) in subparagraph (B), by striking ``; 
                        or'' and inserting ``; or''; and
            (3) in subsection (f)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by inserting ``for the conditionally 
                approved use'' after ``shall''; and
                    (B) in paragraph (2)--
                            (i) by striking ``An intended use'' and 
                        inserting ``The Secretary shall, through 
                        regulation or guidance, determine under what 
                        conditions an intended use''; and
                            (ii) by striking ``shall not'' and 
                        inserting ``may''.
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