Page:United States Statutes at Large Volume 107 Part 3.djvu/304

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107 STAT. 2242 PUBLIC LAW 103-183—DEC. 14, 1993 (2) establishing quality standards under section 354(f) of the Public Healtii Service Act (42 U.S.C. 263b(f)). SEC. 708. SIMPLIFICATION OF VACCINE INFORMATION MATERIALS. (a) INFORMATION.— Section 21260>) of the Public Health Service Act (42 U.S.C. 300aa-26(b)) is amended— (1) by striking 'py rule" in the matter preceding paragraph (1); and (2) by striking, in paragraph (1), ", opportunity for a public hearing, and 90" and inserting "and 60". (b) REQUIREMENTS.— Section 2126(c) of the Public Health Service Act (42 U.S.C. 300aa-26(c)) is amended— (1) by inserting "shall be based on available data and information," after such materials" in the matter preceding paragraph (1); and (2) b}r striking paragraphs (1) through (10) and inserting the following: "(1) a concise description of the benefits of the vaccine, "(2) a concise description of the risks associated with the vaccine, "(3) a statement of the availability of the National Vaccine Ii\jury Compensation Program, and "(4) such other relevant information as may be determined by the Secretary. ". (c) OTHER INDIVIDUALS. — Subsections (a) and (d) of section 2126 of the Public Health Service Act (42 U.S.C. 300aa-26) are each amended by inserting "or to any other individual" after "to the legal representatives of any child". (d) PROVIDERS DUTIES. —Subsection (d) of section 2126 of the Public Health Service Act (42 U.S.C. 300aa-26) is amended— (1) by striking all after "subsection (a)," the second place it appears in the first sentence and inserting "supplemented with visual presentations or oral explanations, in appropriate cases."; and (2) by striking "or other information" in the last sentence. Approved December 14, 1993. LEGISLATIVE HISTORY—H.R. 2202 (S. 1002) (S. 1318): HOUSE REPORTS: Nos. 103-120 (Comm. on Energy and Commerce) and 103-397 (Comm. of Conference). SENATE REPORTS: No. 103-135 accompanying S. 1318 (Comm. on Labor and Human RGsourcGs) CONGRESSIONAL RECORD, Vol. 139 (1993): June 14, considered and passed House. Nov. 2, considered and passed Senate, amended. Nov. 21, House agreed to conference report. Nov. 22, Senate agreed tp conference report. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 29 (1993): Dec. 16, Presidential statement.