b72
<PRE>[DOCID: f:s1341is.txt]
107th CONGRESS
  1st Session
                                S. 1341

  To amend the Internal Revenue Code of 1986 to expand human clinical 
 trials qualifying for the orphan drug credit, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 2, 2001

 Mr. Hatch (for himself, Mr. Kennedy, and Mr. Jeffords) introduced the 
 following bill; which was read twice and referred to the Committee on 
                                Finance

_______________________________________________________________________

                                 A BILL


 
  To amend the Internal Revenue Code of 1986 to expand human clinical 
 trials qualifying for the orphan drug credit, 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. EXPANDED 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 
the Internal Revenue Code of 1986 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 section shall 
apply to amounts paid or incurred after December 31, 2001.

SEC. 2. PUBLICATION OF FILING AND APPROVAL OF REQUESTS FOR DESIGNATION 
              OF DRUGS FOR RARE DISEASES OR CONDITIONS.

    Subsection (c) of section 526 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bb) is amended to read as follows:
    ``(c) Not less than monthly, the Secretary shall publish in the 
Federal Register, and otherwise make available to the public, notice of 
requests for designation of a drug under subsection (a) and approvals 
of such requests. Such notice shall include--
            ``(1) the name and address of the manufacturer and the 
        sponsor;
            ``(2) the date of the request for designation or of the 
        approval of such request;
            ``(3) the nonproprietary name of the drug and the name of 
        the drug under which an application is filed under section 
        505(b) or section 351 of the Public Health Service Act;
            ``(4) the rare disease or condition for which the 
        designation is requested or approved; and
            ``(5) the proposed indication for use of the product.''.
                                 &lt;all&gt;

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