Page:United States Statutes at Large Volume 96 Part 2.djvu/694

 96 STAT. 2056

PUBLIC LAW 97-414—JAN. 4, 1983

treated as being under common control with other trades or business (within the meaning of section 44F(f)(l)(B)), this subsection shall be applied under rules prescribed by the Secretary similar to the rules applicable under subparagraphs (A) and (B) of section 44F(f)(l)." (2)(A) The section heading of section 280C of such Code is amended to read as follows: "SEC. 280C. CERTAIN EXPENSES FOR WHICH CREDITS ARE ALLOWABLE."

(B) The table of sections for part IX of subchapter B of chapter 1 of such Code is amended by striking out the item relating to section 280C and inserting in lieu thereof the following: "Sec. 280C. Certain expenses for which credits are allowable."

(c)(1) The table of sections for subpart A of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 44G the following new item: "Sec. 44H. Clinical testing expenses for certain drugs for rare diseases or conditions." 26 USC 6096. 26 USC 44H note.

(2) Subsection (b) of section 6096 of such Code is amended by striking out "and 44G" and inserting in lieu thereof "44G, and 44H. (d) The amendments made by this section shall apply to amounts paid or incurred after December 31, 1982, in taxable years ending after such date. „. „..__,,,,„ . GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE DISEASES AND CONDITIONS

21 USC 360ee.

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"Qualified clinical testing."

Ante, p. 2050.

21 USC 355. "Rare disease or condition."

SEC. 5. (a) The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions. (b) For purposes of subsection (a): (1) The term "qualified clinical testing" means any human clinical testing— (A) which is carried out under an exemption for a drug irub for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section), (B) which occurs— (i) after the date such drug is designated under section 526 of such Act, and '?,)•;' (ii) before the date on which an application with respect to such drug is submitted under section 5050)) of such Act. (2) The term "rare disease or condition" means any disease or condition which occurs so infrequently in the United States that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made. zi ivjiiW'v ii5';*->niPi? TO i'-f-

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