PUBLIC LAW 100-290—APR. 18, 1988
102 STAT. 91
of developing medical devices for rare diseases or conditions", and (2) in subsection (b)(2)— (A) by inserting "(1) in the case of a drug," after "means" in the first sentence and by adding before the period in that sentence a comma and "(2) in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a)", and (B) by striking out "under this subsection" in the last sentence and inserting in lieu thereof "under section 526 of the Federal Food, Drug, and Cosmetic Act". (b) MEDICAL FOODS.—Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended— (1) in subsection (a) (as amended by subsection (a)), by inserting before the period a comma and "and (3) defraying the costs of developing medical foods for rare diseases or conditions", (2) in subsection (b)(2) (as amended by subsection (a)), by inserting before the period at the end of the first sentence a comma and "and (3) in the case of a medical food, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such disease or condition will be developed without assistance under subsection (a)", and (3) by adding at the end of subsection (b) the following: "(3) The term 'medical food' means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.". (c) AUTHORIZATION.—Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows: "(c) For grants and contracts under subsection (a) there are authorized to be appropriated $10,000,000 for fiscal year 1988, $12,000,000 for fiscal year 1989, $14,000,000 for fiscal year 1990.". (d) STUDY.—The Secretary of Health and Human Services shall conduct a study to determine whether the application of subchapter 21 USC 360aa B of chapter V of the Federal Food, Drug, and Cosmetic Act (relating note. to drugs for rare diseases and conditions) and section 28 of the Internal Revenue Code of 1986 (relating to tax credit) to medical devices or medical foods for rare diseases or conditions or to both is needed to encourage the development of such devices and foods. The Reports. Secretary shall report the results of the study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate not later than one year after the date of the enactment of this Act. For purposes of this section, the term "rare diseases or conditions" has the meaning prescribed by section 5 of the Orphan Drug Act (21 U.S.C. 360ee).
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