Page:United States Statutes at Large Volume 96 Part 2.djvu/691

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2053

consultation shall provide the opportunity for the submission of oral views. "(e) The Board shall submit to the Committee on Labor and Report to Human Resources of the Senate and the Committee on Energy and congressional Commerce of the House of Representatives an annual report— commi "(1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition, "(2) describing the activities of the Board, and "(3) containing the results of the evaluations carried out by the Board. The Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration shall submit to the Board for inclusion in the annual report a .,.., report on the rare disease and condition research activities of the ' ' Institutes of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H of the Internal Revenue Code of 1954; and the Secretary infra. of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under section 5 of the Orphan Drug Act for the development of Post, p. 2056 drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year.". TAX CREDIT FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS

SEC. 4. (a) Subpart A of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1954 (relating to credits allowable) is amended by inserting after section 44G the following new section: "SEC. 44H. CLINICAL TESTING EXPENSES FOR CERTAIN DRUGS FOR RARE DISEASES OR CONDITIONS.

"(a) GENERAL RULE.—There shall be allowed as a credit against the tax imposed by this chapter for the taxable year an amount equal to 50 percent of the qualified clinical testing expenses for the taxable year. "(b) QUALIFIED CUNICAL TESTING EXPENSES.—For purposes of this section— "(1) QUALIFIED CLINICAL TESTING EXPENSES.—

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"(A) IN GENERAL.—Except as otherwise provided in this paragraph, the term 'qualified clinical testing expenses' means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection (b) of section 44F if such subsection were applied with the modifications set forth in subparagraph (B). "(B) MODIFICATIONS.—For purposes of subparagraph (A), subsection (b) of section 44F shall be applied— "(i) by substituting 'clinical testing' for 'qualified research' each place it appears in paragraphs (2) and (3) of such subsection, and "(ii) by substituting '100 percent' for '65 percent' in paragraph (3)(A) of such subsection.

26 USC 44H.

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