H.R. 1451105th CongressHouse Bill

Pediatric Research Initiative Act of 1997

Introduced in the HouseDead

This bill died when its Congress ended.

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TABLE OF CONTENTS: Title I: Biomedical and Behavioral Research Title II: Preventive Health Research Title III: Development of Improved Pharmaceutical and Other Therapeutic Agents Title IV: Research on Environmental Risks Pediatric Research Initiative Act of 1997 - Title I: Biomedical and Behavioral Research - Amends the Public Health Service Act to mandate a comprehensive plan for the conduct and support by the national research institutes of pediatric research. Establishes the National Advisory Council on Pediatric Research. Authorizes appropriations. Requires: (1) guidelines for the inclusion of children as subjects in clinical research projects conducted or supported by the National Institutes of Health; and (2) increasing the percentage of child subjects. Title II: Preventive Health Research - Mandates: (1) a program of research (directly or through grants) regarding preventable diseases, disabilities, and injuries in children; (2) an advisory committee; and (3) a comprehensive plan for the research. Establishes the Pediatric Prevention Research Initiative Fund. Authorizes appropriations. Title III: Development of Improved Pharmaceuticals and Other Therapeutic Agents - Amends the Federal Food, Drug, and Cosmetic Act to delay for a specified time (after the approval would otherwise be granted) the approval of new drugs for which the application materials refer to a drug whose approval application materials include pediatric clinical investigations. Allows the Secretary of Health and Human Services to consider pharmacokinetic studies as clinical investigations. Provides for requests for pediatric studies. Title IV: Research on Environmental Risks - Amends the Public Health Service Act to mandate a program to conduct and support research regarding environmental factors that affect children differently than adults. Authorizes appropriations.

Introduced Apr 24, 1997
1
Introduced

Filed in the House

2
Passed House
3
Passed Senate
4
Became Law

This house bill has been filed and is working its way through Congress. It will need to pass both the House and the Senate, then be signed by the President to become law.

Who introduced this

JM

James Moran

Democrat

U.S. Representative · VA-8

Bipartisan — 35 cosponsors (32 D, 3 R)

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