h 17 57935 1242878400 false 1242878400 2618 194 111 400251

5/21/2009--Introduced.Vaccine Safety and Public Confidence Assurance Act of 2009 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services (HHS). Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.

1242878400 2009-05-21 Fri Nov 13 20:27:19 -0600 2009 introduced 57935 'improv':2 'purpos':9 'safeti':4 'vaccin':3 'research':5 73807 false official introduced 57935 'act':7 '2009':9 'assur':6 'confid':5 'public':4 'safeti':2 'vaccin':1 73806 false short action 57935 1242878400 Thu May 21 00:00:00 -0500 2009 196551 Referred to the House Committee on Energy and Commerce. M000087 1948-02-19 6089 2331 Rayburn House Office Building http://maloney.house.gov/index.php?option=com_email_form&Itemid=73 14 202-225-4709 Carolyn 'd':4 'ny':5 '-14':6 'rep':1 'carolyn':2,7,9 'maloney':3,8,10 F 400251 Maloney Carolyn_B._Maloney B. Rep. Carolyn Maloney [D, NY-14] 2993 N00000078 7775 Democrat 202-225-7944 Presbyterian NY Carolyn Maloney 2.0 http://maloney.house.gov/ S000522 1953-03-04 3345 2373 Rayburn House Office Building http://chrissmith.house.gov/zipauth.html 4 202-225-7768 Christopher 'r':4 '-4':6 'nj':5 'rep':1 'chris':9 'smith':3,8,11 'christoph':2,7,10 M 400380 Smith Christopher_H._Smith H. Rep. Christopher Smith [R, NJ-4] 1323 Chris N00009816 10177 Republican 202-225-3765 Roman Catholic NJ Chris Christopher Smith 1.87878787878788 http://www.house.gov/chrissmith/ USRepChrisSmith action 57935 1242878400 Thu May 21 00:00:00 -0500 2009 196551 Referred to the House Committee on Energy and Commerce. action 57935 1242878400 Thu May 21 00:00:00 -0500 2009 196550 Sponsor introductory remarks on measure. (CR E1240) introduced 57935 1242878400 Thu May 21 00:00:00 -0500 2009 196549