H.R.1735 - Pediatric Research Initiative Act of 1995104th Congress (1995-1996)
|Sponsor:||Rep. Moran, James P. [D-VA-8] (Introduced 05/25/1995)|
|Committees:||House - Commerce|
|Latest Action:||06/19/1995 Referred to the Subcommittee on Health and Environment. (All Actions)|
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Summary: H.R.1735 — 104th Congress (1995-1996)All Bill Information (Except Text)
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
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.