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HR 1735 104th Congress House Health Accident prevention Administrative procedure Child development Child health Child psychology Child welfare Clinical trials Curricula Day care Department of Health and Human Services Drugs Economics and Public Finance Education Educational policy Emergency Management Epidemiology Families Federal advisory bodies Federal aid to medical research

Pediatric Research Initiative Act of 1995

Introduced: May 25, 1995 See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 19, 1995
Referred to the Subcommittee on Health and Environment.
May 25, 1995
Referred to the House Committee on Commerce.
May 25, 1995
Introduced in House
 Plain-English summary Congressional Research Service

TABLE OF CONTENTS:

Title I: Biomedical and Behavioral Research

Title II: Preventive Health Research

Title III: Development of Improved Pharmaceuticals and Other

Therapeutic Agents

Pediatric Research Initiative Act of 1995 - 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.

What's happening now June 19, 1995

Referred to the Subcommittee on Health and Environment.

 Committees of jurisdiction 2
 Cosponsors 5
All 5 Democratic 5