PUBLIC LAW 97-414—JAN. 4, 1983
96 STAT. 2051
for a drug designated under section 526 for a rare disease or Ante, p. 2050. condition and for which a United States Letter of Patent may not be issued, the Secretary may not approve another application under section 505(b) or issue another license under section 351 of the 21 USC 355. Public Health Service Act for such drug for such disease or condi- 42 USC 262. tion for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence. "(b) If an application filed pursuant to section 505(b) is approved for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public Health Service Act for such a drug and if a United States Letter of Patent may not be issued for the drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 505(b), or, if the drug is a biological product, issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if— "(1) The Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the
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holder of the approved application or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or "(2) such holder provides the Secretary in writing the consent 1 of such holder for the approval of other applications or the issuance of other licenses before the expiration of such sevenyear period. "OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS FOR RARE DISEASES OR CONDITIONS
^ "SEC. 528. If a drug is designated under section 526 as a drug for a rare disease or condition and if notice of a claimed exemption under section 505(i) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.". (b) Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting before section 501 the following: "SUBCHAPTER A—DRUGS AND DEVICES.". ORPHAN PRODUCTS BOARD
SEC. 3. Title II of the Public Health Service Act is amended by adding at the end the following:
21 USC 360dd.
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