There is one summary for H.R.1735. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (05/25/1995)

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.