Page:United States Statutes at Large Volume 99 Part 1.djvu/409

 PUBLIC LAW 99-91—AUG. 15, 1985

99 STAT. 387

Public Law 99-91 99th Congress An Act To amend the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act and related laws.

Aug. 15, 1985 rg 1147]

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. Orphan Drug SECTION 1. SHORT TITLE.

This Act may be cited as the "Orphan Drug Amendments of 1985".

Amendments of 1985,

21 USC 30i note.

SEC. 2. MARKET PROTECTION.

Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— (1) by striking out "and for which a United States Letter of Patent may not be issued" in subsection (a); (2) by striking out "and if a United States Letter of Patent may not be issued for the drug" in subsection (b); and (3) by striking out "UNPATENTED" in the title of the section. SEC. 3. ANTIBIOTIC DRUGS. (a) DESIGNATION.—

(1) Section 525(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa(a)) is amended— (A) by striking out "or" at the end of paragraph (1), by redesignating paragraph (2) as paragraph (3), and by inserting after paragraph (1) the following: "(2) if the drug is an antibiotic, it may be certified for such disease or condition under section 507, or; (B) by striking out "before" in paragraph (3) (as so redesignated); (C) by inserting after "505" in the last sentence a comma and the following: "certification of such drug for such disease or condition under section 507,"; and (D) by striking out "licensing under section 351 of the Public Health Service Act for such disease or condition" and inserting in lieu thereof "licensing of such drug for such disease or condition under section 351 of the Public Health Service Act". (2) Section 526(a)(l) of such Act (21 U.S.C. 360bb(a)(l)) is amended— (A) by striking out "or" at the end of subparagraph (A) and by striking out subparagraph (B) and inserting in lieu thereof the following: "(B) if a certification for such drug is issued under section 507, or "(C) if a license for such drug is issued under section 351 of the Public Health Service Act,"; and (B) by striking out "the approval or license" and inserting in lieu thereof "the approval, certification, or license.

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