I 
111TH CONGRESS 
1ST SESSION H. R. 1032 
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 12, 2009 
Mrs. CAPPS (for herself, Mrs. BONO MACK, Mr. ABERCROMBIE, Mr. BACA, 
Ms. BALDWIN, Ms. BEAN, Ms. BERKLEY, Mr. BERMAN, Mrs. BIGGERT, 
Mr. BISHOP of New York, Ms. BORDALLO, Mr. BOUCHER, Ms. CORRINE 
BROWN of Florida, Ms. GINNY BROWN-WAITE of Florida, Mr. BURTON 
of Indiana, Mrs. CAPITO, Mr. CARSON of Indiana, Ms. CASTOR of Flor-
ida, Mrs. CHRISTENSEN, Mr. CUMMINGS, Mrs. DAVIS of California, Ms. 
DEGETTE, Ms. DELAURO, Mr. LINCOLN DIAZ-BALART of Florida, Ms. 
EDWARDS of Maryland, Mrs. EMERSON, Mr. ENGEL, Ms. ESHOO, Mr. 
FORTENBERRY, Mr. FRANK of Massachusetts, Mr. GERLACH, Ms. GIF-
FORDS, Mr. GONZALEZ, Mr. GORDON of Tennessee, Ms. GRANGER, Mr. 
GRAVES, Mr. AL GREEN of Texas, Mr. GENE GREEN of Texas, Mr. 
GRIJALVA, Ms. HARMAN, Mr. HINCHEY, Ms. HIRONO, Mr. HOLT, Mr. 
ISRAEL, Mr. ISSA, Ms. JACKSON-LEE of Texas, Ms. KAPTUR, Mr. KIL-
DEE, Ms. KILPATRICK of Michigan, Ms. LEE of California, Mr. LEVIN, 
Mr. LIPINSKI, Mr. LOBIONDO, Ms. ZOE LOFGREN of California, Mrs. 
LOWEY, Mrs. MALONEY, Mr. MARKEY of Massachusetts, Mr. MARSHALL, 
Ms. MATSUI, Ms. MCCOLLUM, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. 
MCHUGH, Mr. MOORE of Kansas, Ms. MOORE of Wisconsin, Mr. NADLER 
of New York, Mrs. NAPOLITANO, Ms. NORTON, Mr. OBERSTAR, Mr. 
OLVER, Mr. PASCRELL, Ms. PINGREE of Maine, Mr. PLATTS, Mr. 
RADANOVICH, Mr. REYES, Mr. ROGERS of Alabama, Ms. ROS-LEHTINEN, 
Ms. 
ROYBAL-ALLARD, 
Ms. 
SCHAKOWSKY, 
Mrs. 
SCHMIDT, 
Ms. 
SCHWARTZ, Mr. SERRANO, Mr. SESTAK, Ms. SHEA-PORTER, Mr. SIRES, 
Ms. SLAUGHTER, Mr. SMITH of New Jersey, Mr. STARK, Ms. SUTTON, 
Mrs. TAUSCHER, Mr. TAYLOR, Mr. TIERNEY, Ms. TSONGAS, Mr. VAN 
HOLLEN, Mr. WALZ, Ms. WASSERMAN SCHULTZ, Mr. WHITFIELD, Ms. 
WOOLSEY, Mr. WU, Mr. MICHAUD, Mr. PRICE of North Carolina, and 
Mrs. BLACKBURN) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
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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 
(ii) by inserting before the period the 
following: ‘‘; and (H) the information re-
quired under paragraph (7)’’; and 
(B) by adding at the end the following: 
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‘‘(7)(A) With respect to clinical data in an application 
under this subsection, the Secretary may deny such an ap-
plication if the application fails to meet the requirements 
of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 
21, Code of Federal Regulations. 
‘‘(B) The Secretary shall modify the sections referred 
to in subparagraph (A) to require that an application 
under this subsection include any clinical data possessed 
by the applicant that relates to the safety or effectiveness 
of the drug involved by gender, age, and racial subgroup. 
‘‘(C) Promptly after approving an application under 
this subsection, the Secretary shall, through an Internet 
site of the Department of Health and Human Services, 
make available to the public the information submitted to 
the Secretary pursuant to subparagraphs (A) and (B), 
subject to sections 301(j) and 520(h)(4) of this Act, sub-
section (b)(4) of section 552 of title 5, United States Code 
(commonly referred to as the ‘Freedom of Information 
Act’), and other provisions of law that relate to trade se-
crets or confidential commercial information. 
‘‘(D) The Secretary shall develop guidance for staff 
of the Food and Drug Administration to ensure that appli-
cations under this subsection are adequately reviewed to 
determine whether the applications include the informa-
tion required pursuant to subparagraphs (A) and (B).’’. 
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(2) INVESTIGATIONAL
NEW
DRUG
APPLICA-
TIONS.—Section 505(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(i)) is amended— 
(A) in paragraph (2), by striking ‘‘Subject 
to paragraph (3),’’ and inserting ‘‘Subject to 
paragraphs (3) and (5),’’; and 
(B) by adding at the end the following: 
‘‘(5)(A) The Secretary may place a clinical hold (as 
described in paragraph (3)) on an investigation if the 
sponsor of the investigation fails to meet the requirements 
of section 312.33(a) of title 21, Code of Federal Regula-
tions. 
‘‘(B) The Secretary shall modify the section referred 
to in subparagraph (A) to require that reports under such 
section include any clinical data possessed by the sponsor 
of the investigation that relates to the safety or effective-
ness of the drug involved by gender, age, and racial sub-
group.’’. 
(b) BIOLOGICS LICENSE APPLICATIONS.—Section 
351 of the Public Health Service Act (42 U.S.C. 262) is 
amended by adding at the end the following: 
‘‘(k) The provisions of section 505(b)(7) of the Fed-
eral Food, Drug, and Cosmetic Act (relating to clinical 
data submission) apply with respect to an application 
under subsection (a) of this section to the same extent 
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and in the same manner as such provisions apply with re-
spect to an application under section 505(b) of such Act.’’. 
(c) DEVICES.— 
(1) PREMARKET
APPROVAL.—Section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e) is amended— 
(A) in subsection (c)(1)— 
(i) in subparagraph (G)— 
(I) by moving the margin 2 ems 
to the left; and 
(II) by striking ‘‘and’’ after the 
semicolon at the end; 
(ii) by redesignating subparagraph 
(H) as subparagraph (I); and 
(iii) by inserting after subparagraph 
(G) the following subparagraph: 
‘‘(H) the information required under subsection 
(d)(7); and’’; and 
(B) in subsection (d), by adding at the end 
the following paragraph: 
‘‘(7) To the extent consistent with the regulation of 
devices, the provisions of section 505(b)(7) (relating to 
clinical data submission) apply with respect to an applica-
tion for premarket approval of a device under subsection 
(c) of this section to the same extent and in the same man-
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ner as such provisions apply with respect to an application 
for premarket approval of a drug under section 505(b).’’. 
(2) 
INVESTIGATIONAL
DEVICES.—Section 
520(g)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(g)(2)) is amended by adding at 
the end the following subparagraph: 
‘‘(D) To the extent consistent with the regulation of 
devices, the provisions of section 505(i)(5) (relating to in-
dividual study information) apply with respect to an appli-
cation for an exemption pursuant to subparagraph (A) of 
this paragraph to the same extent and in the same manner 
as such provisions apply with respect to an application for 
an exemption under section 505(i).’’. 
(d) RULES OF CONSTRUCTION.—This Act and the 
amendments made by this Act may not be construed— 
(1) as establishing new requirements under the 
Federal Food, Drug, and Cosmetic Act relating to 
the design of clinical investigations that were not 
otherwise in effect on the day before the date of the 
enactment of this Act; or 
(2) as having any effect on the authority of the 
Secretary of Health and Human Services to enforce 
regulations under the Federal Food, Drug, and Cos-
metic Act that are not expressly referenced in this 
Act or the amendments made by this Act. 
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(e) APPLICATION.—This section and the amendments 
made by this section apply only with respect to applica-
tions received under section 505 or 515 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or 
section 351 of the Public Health Service Act (42 U.S.C. 
262) on or after the date of the enactment of this Act. 
SEC. 3. REPORTING AND ANALYSIS OF PATIENT SAFETY 
DATA. 
(a) DATA STANDARDS.—Section 923(b) of the Public 
Health Service Act (42 U.S.C. 299b–23(b)) is amended 
by adding at the end the following: ‘‘The Secretary shall 
provide that all nonidentifiable patient safety work prod-
uct reported to and among the network of patient safety 
databases be stratified by sex.’’. 
(b) USE OF INFORMATION.—Section 923(c) of the 
Public Health Service Act (42 U.S.C. 299b–23(c)) is 
amended by adding at the end the following: ‘‘Such anal-
yses take into account data that specifically relates to 
women and any disparities between treatment and the 
quality of care between males and females.’’. 
SEC. 4. QUALITY OF CARE REPORTS BY THE AGENCY FOR 
HEALTHCARE RESEARCH AND QUALITY. 
Section 903 of the Public Health Service Act (42 
U.S.C. 299a–1) is amended— 
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(1) in subsection (b)(1)(B), by inserting before 
the semicolon the following: ‘‘, and including quality 
of and access to care for women with heart disease, 
stroke, and other cardiovascular diseases’’; and 
(2) in subsection (c), by adding at the end the 
following: 
‘‘(4) ANNUAL REPORT ON WOMEN AND HEART 
DISEASE.—Not later than September 30, 2011, and 
annually thereafter, the Secretary, acting through 
the Director, shall prepare and submit to Congress 
a report concerning the findings related to the qual-
ity of and access to care for women with heart dis-
ease, stroke, and other cardiovascular diseases. The 
report shall contain recommendations for eliminating 
disparities in, and improving the treatment of, heart 
disease, stroke, and other cardiovascular diseases in 
women.’’. 
SEC. 5. EDUCATIONAL CAMPAIGNS. 
(a) DISTRIBUTION OF EDUCATIONAL MATERIAL.— 
The Secretary of Health and Human Services (referred 
to in this section as the ‘‘Secretary’’) shall develop and 
distribute to females who are age 65 or older, physicians, 
and other appropriate healthcare professionals, edu-
cational materials relating to the prevention, diagnosis, 
and treatment of heart disease, stroke, and cardiovascular 
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diseases in women. The Secretary may carry out this sub-
section through contracts with public and private non-
profit entities. 
(b) HEALTHCARE
PROFESSIONAL
EDUCATIONAL 
CAMPAIGN.—The Secretary, acting through the Bureau of 
Health Professions of the Health Resources and Services 
Administration, shall conduct an education and awareness 
campaign for physicians and other healthcare profes-
sionals relating to the prevention, diagnosis, and treat-
ment of heart disease, stroke, and other cardiovascular 
diseases in women. The Bureau of Health Professions may 
carry out this subsection through contracts with public 
and private nonprofit entities. 
SEC. 6. EXTENSION OF WISEWOMAN PROGRAM. 
Section 1509 of the Public Health Service Act (42 
U.S.C. 300n–4a) is amended— 
(1) in subsection (a)— 
(A) by striking the heading and inserting 
‘‘IN GENERAL.—’’; and 
(B) in the matter preceding paragraph (1), 
by striking ‘‘may make grants’’ and all that fol-
lows through ‘‘purpose’’ and inserting the fol-
lowing: ‘‘may make grants to such States for 
the purpose’’; and 
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(2) in subsection (d)(1), by striking ‘‘there are 
authorized’’ and all that follows through the period 
and inserting ‘‘there are authorized to be appro-
priated 
$70,000,000 
for 
fiscal 
year 
2010, 
$73,500,000 for fiscal year 2011, $77,000,000 for 
fiscal year 2012, $81,000,000 for fiscal year 2013, 
and $85,000,000 for fiscal year 2014.’’. 
Æ 
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