3.0.0 422 2020-02-10T17:01:05Z 2020-02-10T17:01:05Z Senate S S 2009-02-12 111 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2009-02-12T18:58:46Z HEART for Women Act 111 1032 HR 2010-11-15 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2009-02-12 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2009-02-12 Sponsor introductory remarks on measure. (CR S2230-2232) IntroReferral B00100 9 Library of Congress 2009-02-12 Introduced in Senate IntroReferral 10000 9 Library of Congress S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI N M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2009-02-12 True F000062 Sen. Feinstein, Dianne [D-CA] Dianne Feinstein D CA 2009-02-12 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2009-02-12 True L000035 Sen. Lincoln, Blanche L. [D-AR] BLANCHE LINCOLN D AR LAMBERT 2009-02-12 True C000286 Sen. Chambliss, Saxby [R-GA] SAXBY CHAMBLISS R GA 2009-02-12 True M000702 Sen. Mikulski, Barbara A. [D-MD] BARBARA MIKULSKI D MD ANN 2009-02-12 True C000567 Sen. Cochran, Thad [R-MS] Thad Cochran R MS 2009-02-12 True L000550 Sen. Landrieu, Mary L. [D-LA] MARY LANDRIEU D LA 2009-02-12 True B000711 Sen. Boxer, Barbara [D-CA] BARBARA BOXER D CA 2009-02-12 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2009-02-12 True C000141 Sen. Cardin, Benjamin L. [D-MD] Ben Cardin D MD 2009-02-12 True K000148 Sen. Kerry, John F. [D-MA] JOHN KERRY D MA FORBES 2009-02-12 True W000802 Sen. Whitehouse, Sheldon [D-RI] Sheldon Whitehouse D RI 2009-02-12 True A000069 Sen. Akaka, Daniel K. [D-HI] DANIEL AKAKA D HI KOHIKINA 2009-02-12 True S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2009-02-12 True I000025 Sen. Inouye, Daniel K. [D-HI] DANIEL INOUYE D HI KEN 2009-02-12 True B001265 Sen. Begich, Mark [D-AK] Mark Begich D AK 2009-02-12 True C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2009-02-12 True M000639 Sen. Menendez, Robert [D-NJ] Robert Menendez D NJ 2009-02-12 True B001233 Sen. Bayh, Evan [D-IN] EVAN BAYH D IN 2009-02-12 True C000174 Sen. Carper, Thomas R. [D-DE] Thomas Carper D DE R. 2009-02-12 True W000779 Sen. Wyden, Ron [D-OR] Ron Wyden D OR 2009-02-12 True C000705 Sen. Conrad, Kent [D-ND] KENT CONRAD D ND 2009-02-12 True D000432 Sen. Dorgan, Byron L. [D-ND] BYRON DORGAN D ND LESLIE 2009-02-23 False L000261 Sen. Levin, Carl [D-MI] CARL LEVIN D MI MILTON 2009-02-23 False C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX 2009-02-23 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2009-02-25 False J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2009-02-26 False M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2009-03-03 False T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2009-03-03 False L000304 Sen. Lieberman, Joseph I. [ID-CT] JOSEPH LIEBERMAN ID CT I. 2009-03-04 False K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2009-03-16 False D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2009-03-16 False B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2009-03-16 False L000123 Sen. Lautenberg, Frank R. [D-NJ] FRANK LAUTENBERG D NJ R. 2009-03-16 False H001016 Sen. Hutchison, Kay Bailey [R-TX] KAY HUTCHISON R TX BAILEY 2009-03-17 False G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. 2009-03-19 False S000663 Sen. Snowe, Olympia J. [R-ME] Olympia Snowe R ME J. 2009-03-26 False U000039 Sen. Udall, Tom [D-NM] TOM UDALL D NM 2009-04-29 False H001049 Sen. Hagan, Kay R. [D-NC] Kay Hagan D NC R. 2009-07-07 False C000127 Sen. Cantwell, Maria [D-WA] Maria Cantwell D WA 2009-08-06 False F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2009-08-06 False S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2009-09-09 False B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2010-02-24 False Health Cardiovascular and respiratory health Drug safety, medical device, and laboratory regulation Government information and archives Health care quality Health information and medical records Health programs administration and funding Health promotion and preventive care Licensing and registrations Medical education Medical research Prescription drugs Women's health Health 00 2009-02-12 Introduced in Senate 2009-03-03T20:49:05Z Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.

Directs the Secretary to: (1) require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup; and (2) develop guidance for the staff of the Food and Drug Administration (FDA) to ensure that new drug applications are adequately reviewed to determine whether they include the required clinical data.

Authorizes the Secretary to place a clinical hold on an investigation under an investigational new drug application if the sponsor of the investigation fails to meet the requirements of an annual report on the status of each study in progress.

Applies provisions relating to clinical data submission for new drug applications to applications for an investigational new drug, a biologics license for a biological product, premarket approval for a class III device, and investigational use of a device.

Amends the Public Health Service Act to require the Secretary to provide that all nonidentifiable patient safety work product reported to and among the network of patient safety databases be identified by sex.

Directs that analyses of statistics of information reported to the network of patient safety databases take into account data that specifically relates to women and any disparities between treatment and the quality of care between males and females.

Requires the Director of the Agency for Healthcare Research and Quality to support research and demonstrations to identify and evaluate clinical and organizational strategies to improve the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.

Requires the Secretary to: (1) distribute to females age 65 or older and appropriate health care professionals educational materials relating to the prevention diagnosis and treatment of heart disease, stroke, and cardiovascular diseases in women; and (2) conduct an education and awareness campaign for health care professionals relating to such diagnosis and treatment.

Expands the grant program authorizing the Secretary to award grants for preventive health services to all states.

]]> HEART for Women Act Short Titles as Introduced Heart Disease Education, Analysis Research, and Treatment for Women Act Short Titles as Introduced HEART for Women Act Display Title HEART for Women Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. Introduced in Senate 2009-02-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s422is/xml/BILLS-111s422is.xml 2009-02-12 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.