§526. Shipowners’ protection and indemnity associations — Inbound Citations
26 U.S.C. § 526
Cited by 5 provisions in release 119-102.
Citations to 26 U.S.C. § 526 as a whole
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(I) after the date such drug is designated under section 526 of such Act, and
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(iii) which is conducted by or on behalf of the taxpayer to whom the designation under such section 526 applies.
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(B) Human clinical testing shall be taken into account under subparagraph (A) only to the extent such testing is related to the use of a drug for the rare disease or condition for which it was designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
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(1) For purposes of this section, the term “rare disease or condition” means any disease or condition which—(A) affects less than 200,000 persons in the United States, or(B) affects more than 200,000 persons in the United States but for which 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 such drug is designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
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(B) such testing is conducted by a United States person or by any other person who is not related to the taxpayer to whom the designation under section 526 of the Federal Food, Drug, and Cosmetic Act applies.