To provide for the expansion of human clinical trials qualifying for the orphan drug credit.

July 25, 2003

Mr. BRADY of Texas (for himself and Mr. MATSUI) introduced the following bill; which was referred to the Committee on Ways and Means

To provide for the expansion of human clinical trials qualifying for the orphan drug credit.

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 `Orphan Drug Tax Credit Act of 2003'.

SEC. 2. EXPANSION OF HUMAN CLINICAL TRIALS QUALIFYING FOR ORPHAN DRUG CREDIT.

(a) IN GENERAL- Subclause (I) of section 45C(b)(2)(A)(ii) of the Internal Revenue Code of 1986 is amended to read as follows:

`(I) after the date that the application is filed for designation under such section 526, and'.

(b) CONFORMING AMENDMENT- Clause (i) of section 45C(b)(2)(A) of such Code is amended by inserting `which is' before `being' and by inserting before the comma at the end `and which is designated under section 526 of such Act'.

(c) EFFECTIVE DATE- The amendments made by this Act shall apply to amounts paid or incurred after the date of the enactment of this Act.

END