[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3815 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 3815

  To amend the Internal Revenue Code of 1986 to provide for a medical 
     innovation tax credit for clinical testing research expenses 
 attributable to academic medical centers and other qualified hospital 
                        research organizations.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 1998

   Mr. Sam Johnson of Texas (for himself, Mr. Levin, Mr. English of 
 Pennsylvania, Mr. Houghton, Mr. Price of North Carolina, Ms. Lofgren, 
  Mr. Dooley of California, and Mr. Bentsen) introduced the following 
      bill; which was referred to the Committee on Ways and Means

_______________________________________________________________________

                                 A BILL


 
  To amend the Internal Revenue Code of 1986 to provide for a medical 
     innovation tax credit for clinical testing research expenses 
 attributable to academic medical centers and other qualified hospital 
                        research organizations.

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

SECTION 1. CREDIT FOR CLINICAL TESTING RESEARCH EXPENSES ATTRIBUTABLE 
              TO CERTAIN QUALIFIED ACADEMIC INSTITUTIONS INCLUDING 
              TEACHING HOSPITALS.

    (a) In General.--Subpart D of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 (relating to business related 
credits) is amended by inserting after section 41 the following:

``SEC. 41A. CREDIT FOR MEDICAL INNOVATION EXPENSES.

    ``(a) General Rule.--For purposes of section 38, the medical 
innovation credit determined under this section for the taxable year 
shall be an amount equal to 20 percent of the excess (if any) of--
            ``(1) the qualified medical innovation expenses for the 
        taxable year, over
            ``(2) the medical innovation base period amount.
    ``(b) Qualified Medical Innovation Expenses.--For purposes of this 
section--
            ``(1) In general.--The term `qualified medical innovation 
        expenses' means the amounts which are paid or incurred by the 
        taxpayer during the taxable year directly or indirectly to any 
        qualified academic institution for clinical testing research 
        activities.
            ``(2) Clinical testing research activities.--
                    ``(A) In general.--The term `clinical testing 
                research activities' means human clinical testing 
                conducted at any qualified academic institution in the 
                development of any product, which occurs before--
                            ``(i) the date on which an application with 
                        respect to such product is approved under 
                        section 505(b), 506, or 507 of the Federal 
                        Food, Drug, and Cosmetic Act,
                            ``(ii) the date on which a license for such 
                        product is issued under section 351 of the 
                        Public Health Service Act, or
                            ``(iii) the date classification or approval 
                        of such product which is a device intended for 
                        human use is given under section 513, 514, or 
                        515 of the Federal Food, Drug, and Cosmetic 
                        Act.
                    ``(B) Product.--The term `product' means any drug, 
                biologic, or medical device.
            ``(3) Qualified academic institution.--The term `qualified 
        academic institution' means any of the following institutions:
                    ``(A) Educational institution.--A qualified 
                organization described in section 170(b)(1)(A)(iii) 
                which is owned or affiliated with an institution of 
                higher education as described in section 3304(f).
                    ``(B) Charitable research hospital.--A charitable 
                research hospital which--
                            ``(i) is owned by an organization described 
                        in section 501(c)(3) and exempt from taxation 
                        under section 501(a),
                            ``(ii) is not a private foundation, and
                            ``(iii) is designated as a cancer center by 
                        the National Cancer Institute.
            ``(4) Exclusion for amounts funded by grants, etc.--The 
        term `qualified medical innovation expenses' shall not include 
        any amount to the extent such amount is funded by any grant, 
        contract, or otherwise by another person (or any governmental 
        entity).
    ``(c) Medical Innovation Base Period Amount.--For purposes of this 
section, the term `medical innovation base period amount' means the 
average annual qualified medical innovation expenses paid by the 
taxpayer during the 3-taxable year period ending with the taxable year 
immediately preceding the first taxable year of the taxpayer beginning 
after December 31, 1997.
    ``(d) Special Rules.--
            ``(1) Limitation on foreign testing.--No credit shall be 
        allowed under this section with respect to any clinical testing 
        research activities conducted outside the United States.
            ``(2) Certain rules made applicable.--Rules similar to the 
        rules of subsections (f) and (g) of section 41 shall apply for 
        purposes of this section.
            ``(3) Election.--This section shall apply to any taxpayer 
        for any taxable year only if such taxpayer elects (at such time 
        and in such manner as the Secretary may by regulation 
        prescribe) to have this section apply for such taxable year.
            ``(4) Coordination with credit for increasing research 
        expenditures and with credit for clinical testing expenses for 
        certain drugs for rare diseases.--Any qualified medical 
        innovation expense for a taxable year to which an election 
        under this section applies shall not be taken into account for 
        purposes of determining the credit allowable under section 41 
        or 45C for such taxable year.''
    (b) General Business Credit.--Section 38(b) of the Internal Revenue 
Code of 1986 (relating to current year business credit) is amended by 
striking ``plus'' at the end of paragraph (11), by striking the period 
at the end of paragraph (12) and inserting ``, plus'', and by adding at 
the end the following:
            ``(13) the medical innovation expenses credit determined 
        under section 41A(a).''
    (c) Deduction for Unused Portion of Credit.--Section 196(c) of the 
Internal Revenue Code of 1986 (defining qualified business credits) is 
amended by striking ``and'' at the end of paragraph (6), by striking 
the period at the end of paragraph (7) and inserting ``, and'', and by 
adding at the end the following:
            ``(8) the medical innovation expenses credit determined 
        under section 41A(a).''
    (d) Conforming Amendment.--The table of sections for subpart D of 
part IV of subchapter A of chapter 1 of the Internal Revenue Code of 
1986 is amended by adding after the item relating to section 41 the 
following:

                                  ``Sec. 41A. Credit for medical 
                                        innovation expenses.''
    (e) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 1997.
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