Sec. 104. Modifications to priority review voucher program for tropical diseases
537 words·~2 min read·
/bill/114/hr/786/ih/section-104A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 524 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n ) is amended— in subsection (a)— in paragraph (3)— in the matter before subparagraph (A), by striking This term and inserting In this section, this term ; and in subparagraph (R), by striking designated by order of the Secretary and inserting designated by the Secretary pursuant to paragraph
(4); by redesignating paragraph
(4)as paragraph (5); and by inserting after paragraph
(3)the following: The Secretary shall establish a process under which the Secretary— using a methodology that is made available to the public on the Internet site of the Food and Drug Administration, designates infectious diseases other than the diseases specified in subparagraphs
(A)through
(Q)of paragraph
(3)to be tropical diseases for purposes of this section; and publishes on such Internet site a complete, updated list of the diseases that are tropical diseases for purposes of this section. In designating an infectious disease as a tropical disease under subparagraph (A), the Secretary shall— consider the potential impact of the disease on the public health due to— the potential rate of spread of the disease; and the potential severity of the disease in terms of human morbidity and mortality; and consult with experts in tropical infectious diseases, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, the clinical research community, and the World Health Organization. Every 5 years, or more frequently as determined necessary by the Secretary, the Secretary shall review, provide modifications to, and re-publish the list published under subparagraph
(A)and any revisions made to the methodology for designation of diseases under such subparagraph. ; in subsection (b)— in paragraph (2), by striking The sponsor of a tropical disease and inserting: The sponsor of a tropical disease ; by inserting after such paragraph (2)(A) the following: Each person to whom a priority review voucher is transferred shall notify the Secretary of such change in ownership of the voucher not later than 30 business days after such transfer. ; in paragraph (4), by striking The sponsor of a human drug application and inserting: The sponsor of a human drug application ; and by inserting after paragraph (4)(A), as designated by subparagraph (D), the following: The sponsor of a human drug application that provides notification of intent under subparagraph
(A)may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification. Upon such a transfer, notwithstanding subparagraph (A), such sponsor shall not remain legally committed to pay a user fee because of the sponsor’s notification of intent under such subparagraph. ; and in subsection (c), by amending paragraph
(2)to read as follows: The amount of the priority review user fee shall be determined each fiscal year by the Secretary based on the difference between— the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year; and the average cost incurred by the Food and Drug Administration in the review of a human drug application that is not subject to priority review in the previous fiscal year. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 104
Modifications to priority review voucher program for tropical diseases
Cites 1Cited by 0 across 0 sources