IB 
Union Calendar No. 570 
110TH CONGRESS 
2D SESSION 
H. R. 1014 
[Report No. 110–874] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 13, 2007 
Mrs. CAPPS (for herself and Mrs. CUBIN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
SEPTEMBER 23, 2008 
Additional sponsors: Mr. GORDON of Tennessee, Mr. ROSS, Mr. OLVER, Mr. 
MCNULTY, Mr. BISHOP of New York, Mr. BUTTERFIELD, Mrs. MCCAR-
THY of New York, Mr. DELAHUNT, Ms. SLAUGHTER, Ms. LORETTA 
SANCHEZ of California, Mrs. DAVIS of California, Ms. MCCOLLUM of 
Minnesota, Mr. TERRY, Ms. HIRONO, Ms. HOOLEY, Ms. KILPATRICK, Mr. 
MEEHAN, Ms. SCHAKOWSKY, Mr. GRIJALVA, Ms. HERSETH SANDLIN, 
Mrs. CAPITO, Mr. CLAY, Mr. REYES, Mr. SHAYS, Mr. MCDERMOTT, Ms. 
NORTON, Ms. ESHOO, Mr. CUMMINGS, Mr. BOSWELL, Mr. AL GREEN of 
Texas, Mrs. TAUSCHER, Mr. PRICE of North Carolina, Mrs. LOWEY, Ms. 
BORDALLO, Mr. LYNCH, Mr. MCCOTTER, Mr. WU, Mr. VAN HOLLEN, 
Mr. LANTOS, Ms. ZOE
LOFGREN
of California, Mr. STARK, Mr. 
HINOJOSA, Mr. HASTINGS of Florida, Mr. GENE GREEN of Texas, Mr. 
GERLACH, Mr. ELLISON, Mr. BERMAN, Ms. MILLENDER-MCDONALD, 
Ms. LINDA T. SA´NCHEZ of California, Ms. SOLIS, Mr. MELANCON, Mr. 
PLATTS, Mr. BRADY of Pennsylvania, Mr. RUSH, Ms. BERKLEY, Mr. 
COHEN, Mr. RODRIGUEZ, Mr. FILNER, Mr. KENNEDY, Ms. SUTTON, Mr. 
BOUCHER, Mrs. BOYDA of Kansas, Mr. RANGEL, Mr. MARSHALL, Mr. 
MCHUGH, Mr. JINDAL, Ms. FALLIN, Mr. GONZALEZ, Mr. ISSA, Mr. 
WAXMAN, Mr. HINCHEY, Mr. LAMPSON, Mr. ALLEN, Mrs. NAPOLITANO, 
Mr. WEXLER, Mr. MARKEY, Mr. SULLIVAN, Ms. MOORE of Wisconsin, 
Mr. MOORE of Kansas, Mr. ARCURI, Mr. STUPAK, Mr. SAXTON, Mrs. 
JONES of Ohio, Mr. HONDA, Ms. DELAURO, Mr. ETHERIDGE, Mrs. 
MALONEY of New York, Ms. JACKSON-LEE of Texas, Mr. ROTHMAN, Mr. 
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WYNN, Ms. WOOLSEY, Mr. OBERSTAR, Ms. CORRINE BROWN of Florida, 
Mrs. BONO MACK, Mr. REHBERG, Mr. ORTIZ, Mr. CARSON, Mr. GOODE, 
Ms. MATSUI, Ms. DEGETTE, Mr. FARR, Mr. ABERCROMBIE, Mr. FER-
GUSON, Mrs. SCHMIDT, Ms. CASTOR, Ms. GRANGER, Ms. SCHWARTZ, Ms. 
HARMAN, Mrs. GILLIBRAND, Ms. EDDIE BERNICE JOHNSON of Texas, 
Ms. KAPTUR, Ms. CLARKE, Mr. LOEBSACK, Mr. PERLMUTTER, Mr. MUR-
THA, Ms. ROS-LEHTINEN, Mrs. CHRISTENSEN, Mr. THOMPSON of Mis-
sissippi, Mr. PASTOR, Ms. BALDWIN, Mr. ALTMIRE, Mr. BONNER, Mr. 
MCGOVERN, Ms. WATSON, Mr. WAMP, Ms. SHEA-PORTER, Mr. SES-
SIONS, Mr. BISHOP of Utah, Mr. SOUDER, Ms. LEE, Ms. WASSERMAN 
SCHULTZ, Mr. ENGEL, Mrs. MYRICK, Mr. TOWNS, Mrs. BLACKBURN, Ms. 
PRYCE of Ohio, Mr. NEAL of Massachusetts, Mr. MICHAUD, Mr. WELLER 
of Illinois, Mr. ISRAEL, Mr. KIND, Mr. LANGEVIN, Mr. HARE, Mr. BUR-
GESS, Mr. TIERNEY, Ms. WATERS, Mr. WELCH of Vermont, Mr. PAYNE, 
Mr. FRANK of Massachusetts, Mr. JOHNSON of Georgia, Mr. WALSH of 
New York, Mr. KUHL of New York, Mr. KANJORSKI, Mr. LIPINSKI, Mr. 
MILLER of North Carolina, Mr. FORTENBERRY, Mr. GRAVES, Mr. BUR-
TON of Indiana, Mr. CARTER, Ms. BEAN, Mr. UDALL of Colorado, Mr. 
JACKSON of Illinois, Mr. BOREN, Ms. ROYBAL-ALLARD, Ms. VELA´ZQUEZ, 
Mr. YARMUTH, Mr. WEINER, Mrs. MILLER of Michigan, Ms. GIFFORDS, 
Mrs. DRAKE, Mr. DOYLE, Mr. ALEXANDER, Mr. JONES of North Caro-
lina, Mr. PETERSON of Minnesota, Mr. ENGLISH of Pennsylvania, Mrs. 
BIGGERT, Mr. BARROW, Mr. EMANUEL, Mr. WELDON of Florida, Mr. 
HOLDEN, Mr. RUPPERSBERGER, Mr. MORAN of Virginia, Mr. GEORGE 
MILLER of California, Mr. KILDEE, Mr. JEFFERSON, Mr. EDWARDS, Mr. 
MATHESON, Mr. ROGERS of Alabama, Mrs. EMERSON, Mrs. BACHMANN, 
Mrs. MCMORRIS RODGERS, Mrs. JO ANN DAVIS of Virginia, Mrs. WIL-
SON of New Mexico, Mr. RADANOVICH, Ms. GINNY BROWN-WAITE of 
Florida, Mr. NADLER, Mr. SIRES, Mr. HODES, Mr. SMITH of New Jer-
sey, Mr. BISHOP of Georgia, Mr. FORTUN˜O, Mr. SERRANO, Mr. PICK-
ERING, Mr. ELLSWORTH, Mr. LOBIONDO, Mr. LINCOLN DAVIS of Ten-
nessee, Mr. WOLF, Mr. COURTNEY, Mr. HOLT, Ms. TSONGAS, Mr. CAL-
VERT, Mr. SPACE, Mr. PASCRELL, Mr. CUELLAR, Mr. MCINTYRE, Mr. 
HALL of Texas, Mr. SMITH of Washington, Mr. CARSON, Mr. LEWIS of 
Georgia, Mr. RAHALL, Ms. RICHARDSON, Mr. GUTIERREZ, Mr. RAMSTAD, 
Mr. LINCOLN DIAZ-BALART of Florida, Mr. MARCHANT, Mr. TAYLOR, 
Mr. KAGEN, Mr. FOSTER, Mr. KIRK, Mr. WALZ of Minnesota, Mr. 
UPTON, Mr. BLUMENAUER, Mr. TIM MURPHY of Pennsylvania, Mr. 
WITTMAN of Virginia, Mr. SCALISE, Mr. LAHOOD, and Mr. FATTAH 
SEPTEMBER 23, 2008 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
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[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on February 13, 2007] 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Heart Disease Edu-
cation, Analysis Research, and Treatment for Women Act’’ 
or the ‘‘HEART for Women Act’’. 
SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, 
BIOLOGICS, AND DEVICES. 
(a) DRUGS.— 
(1) NEW DRUG APPLICATIONS.—Section 505(b) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) is amended— 
(A) in paragraph (1), in the second sen-
tence— 
(i) by striking ‘‘drug, and (G)’’ and 
inserting ‘‘drug; (G)’’; and 
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