Silicone Breast Implant Research and Information Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Jun 10, 1998)
Silicone Breast Implant Research and Information Act - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to: (1) appoint an official of the Department of Health and Human Services to serve as the NIH coordinator regarding silicone breast implant research; (2) establish either a study section or special emphasis panel for NIH to review extramural silicone breast implant research grant applications to ensure research design and quality, as well as quality intramural research; and (3) conduct or support research to expand the understanding of the health implications of silicone breast implants.
Directs the Commissioner of Food and Drugs to: (1) take specified steps to make updated information about the risks of silicone breast implant available to the public, via the toll-free Consumer Information Line and other means; (2) revise the breast implant information update to clarify the procedure for reporting implant problems; (3) require manufacturers to update implant package inserts and informed consent documents regularly with accurate information; and (4) require any manufacturer conducting an adjunct study on implants to take specified measures with respect to informed consent documents, including informing women on how to obtain a Medwatch form and encouraging women who withdraw from the study, or who would like to report a problem, to submit such a form.
Establishes the President's Interagency Committee on Silicone Breast Implants to ensure strategic management, communication, and oversight of Federal policy formation, research, and activities regarding silicone breast implants.
Authorizes appropriations.
What just happenedJun 29, 1998
Referred to the Subcommittee on Health and Environment.
Who’s behind it
- Introduced in HouseJun 10, 1998
- Jun 29, 1998CommitteeH11000
Referred to the Subcommittee on Health and Environment.
Health and Environment Subcommittee - Jun 10, 1998IntroReferralH11100
Referred to the House Committee on Commerce.
Energy and Commerce Committee - Jun 10, 1998IntroReferralB00100
Sponsor introductory remarks on measure. (CR E1089-1090)
- Jun 10, 1998IntroReferralIntro-H
Introduced in House
- Jun 10, 1998IntroReferral1000
Introduced in House