FULL COMMITTEE ACTION

Thursday, September 25, 1997

Prepared by the Commerce Committee Democratic Staff
H.R. 1411: PRESCRIPTION DRUG USER FEE REAUTHORIZATION AND DRUG REGULATORY MODERNIZATION ACT OF 1997 , was ORDERED FAVORABLY REPORTED, AMENDED, by a yea-nay vote: 43-0.

A Committee Print of H.R. 1411, showing the text of the bill as reported by the Subcommitee on Health and Environment on September 17, 1997, was made in order as original text for purposes of amendment.

The following amendments were offered:

An amendment in the nature of a substitute by Mr. Burr, #1, was ADOPTED, as amended, by a voice vote;

An amendment to the Burr amendment in the nature of a substitute by Mr. Stearns, #1A, re: chlorofluorocarbons in metered-dose inhalers, was WITHDRAWN with no objection;

An amendment to the Burr amendment in the nature of a substitute by Mr. Rush, #1B, re: inclusion of women and minorities in clinical research, was ADOPTED by a voice vote;

An amendment to the Burr amendment in the nature of a substitute by Mr. Burr, #1C, re: applicability of exclusivity incentives for antibiotic drugs, was ADOPTED by a voice vote;

An amendment to the Burr amendment in the nature of a substitute by Mr. Brown, #1D, re: citizens' petitions, was WITHDRAWN with no objection;

An amendment to the Burr amendment in the nature of a substitute by Mr. Deutsch, #1E, re: applicability of exclusivity incentives for antibiotic drugs, was WITHDRAWN with no objection;

An amendment to the Burr amendment in the nature of a substitute by Mr. Waxman, #1F, re: exemption from filing supplemental application for off-label use, was WITHDRAWN with no objection;

An amendment to the Burr amendment in the nature of a substitute by Mr. Deutsch, #1G, re: timeframes for completing pediatric studies, was DEFEATED by a yea-nay vote: 9-32;

An amendment to the Burr amendment in the nature of a substitute by Mr. Pallone, #1H, re: notification of discontinuance of a life saving product, was ADOPTED by a yea-nay vote: 21-20;

An amendment to the Burr amendment in the nature of a substitute by Mr. Deutsch, #1I, re: report on economic impact of pediatric studies, was ADOPTED by a voice vote;

An amendment to the Burr amendment in the nature of a substitute by Mr. Brown, #1J, re: appropriations for dissemination of treatment information, was DEFEATED by a yea-nay vote: 7-36;

An amendment to the Burr amendment in the nature of a substitute by Mr. Pallone, #1K, re: study of mercury sales, was ADOPTED by a voice vote;

An amendment to the Burr amendment in the nature of a substitute by Mr. Pallone, #1L, re: State initiatives regarding national uniformity for nonprescription drugs and cosmetics, was DEFEATED by a voice vote.

H.R. 2469: FOOD AND NUTRITION INFORMATION REFORM ACT OF 1997 , was ORDERED FAVORABLY REPORTED, AMENDED, by a yea-nay vote: 43-0.

A Committee Print of H.R. 2469, showing the text of the bill as reported by the Subcommitee on Health and Environment on September 17, 1997, was made in order as original text for purposes of amendment.

The following amendments were offered:

An amendment in the nature of a substitute by Mr. Whitfield, #1, was ADOPTED, as amended, by a voice vote;

An amendment to the Whitfield amendment in the nature of a substitute by Mr. Stupak, #1A, re: food contact substances, was ADOPTED by a voice vote;

An amendment to theWhitfield amendment in the nature of a substitute by Mr. Klink, #1B, re: glass and ceramic ware, was ADOPTED by a voice vote.

The Committee adjourned until 9:30 a.m. on Friday, September 26, 1997

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