Page:United States Statutes at Large Volume 96 Part 2.djvu/688

 96 STAT. 2050

"(2) if the drug is a biological product, before it may be licensed for such disease or condition under section 351 of the Public Health Service Act. If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 505 or licensing under section 351 of the Public Health Service Act for such disease or condition. "(b) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

42 USC 262.

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PUBLIC LAW 97-414—JAN. 4, 1983

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21 USC 355.

DESIGNATION OF DRUGS FOR RARE DISEASES OR CONDITIONS 21 USC 360bb.

"Rare disease or condition."

Notice.

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21 USC 360CC.

"SEC. 526. (a)(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— "(A) if an application for such drug is approved under section 505, or "(B) if the drug is a biological product, a license is issued under section 351 of the Public Health Service Act, the approval or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) respecting the designation of the drug. "(2) For purposes of paragraph (1), 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. "(b) Notice respecting the designation of a drug under subsection (a) shall be made available to the public. "(c) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a). PROTECTION FOR UNPATENTED DRUGS FOR RARE DISEASES OR CONDITIONS

"SEC. 527. (a) Except as provided in subsection (b), if the Secretary— "(1) approves an application filed pursuant to section 505(b), or "(2) issues a license under section 351 of the Public Health Service Act

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