SEPTEMBER 28, 2010 
Reported with amendments, committed to the Committee of the Whole House 
on the State of the Union, and ordered to be printed 
[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 12, 2009] 
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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. 
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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. REPORT BY GOVERNMENT ACCOUNTABILITY OF-
FICE. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study investigating the extent 
to which sponsors of clinical studies of investigational 
drugs, biologics, and devices and sponsors of applications 
for approval or licensure of new drugs, biologics, and de-
vices comply with Food and Drug Administration require-
ments and follow guidance for presentation of clinical study 
safety and effectiveness data by sex, age, and racial sub-
groups. 
(b) REPORT BY GAO.— 
(1) SUBMISSION.—Not later than 12 months 
after the date of the enactment of this Act, the Comp-
troller General shall complete the study under sub-
section (a) and submit to the Committee on Energy 
and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and 
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Pensions of the Senate a report on the results of such 
study. 
(2) CONTENTS.—The report required by para-
graph (1) shall include each of the following: 
(A) A description of the extent to which the 
Food and Drug Administration assists sponsors 
in complying with the requirements and fol-
lowing the guidance referred to in subsection (a). 
(B) A description of the effectiveness of the 
Food and Drug Administration’s enforcement of 
compliance with such requirements. 
(C) An analysis of the extent to which fe-
males, racial and ethnic minorities, and adults 
of all ages are adequately represented in Food 
and 
Drug 
Administration-approved 
clinical 
studies (at all phases) so that product safety and 
effectiveness data can be evaluated by gender, 
age, and racial subgroup. 
(D) An analysis of the extent to which a 
summary of product safety and effectiveness data 
disaggregated by sex, age, and racial subgroup is 
readily available to the public in a timely man-
ner by means of the product label or the Food 
and Drug Administration’s Website. 
(E) Appropriate recommendations for— 
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(i) modifications to the requirements 
and guidance referred to in subsection (a); 
or 
(ii) oversight by the Food and Drug 
Administration of such requirements. 
(c) REPORT BY HHS.—Not later than 6 months after 
the submission by the Comptroller General of the report re-
quired under subsection (b), the Secretary of Health and 
Human Services shall submit to the Committee on Energy 
and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of 
the Senate a response to that report, including a corrective 
action plan as needed to respond to the recommendations 
in that report. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘biologic’’ has the meaning given 
to the term ‘‘biological product’’ in section 351(i) of 
the Public Health Service Act (42 U.S.C. 262(i)). 
(2) The term ‘‘device’’ has the meaning given to 
such term in section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h)). 
(3) The term ‘‘drug’’ has the meaning given to 
such term in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)). 
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SEC. 3. REPORTING ON QUALITY OF AND ACCESS TO CARE 
FOR WOMEN WITH CARDIOVASCULAR DIS-
EASES. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 399V–5. REPORTING ON QUALITY OF AND ACCESS TO 
CARE FOR WOMEN WITH CARDIOVASCULAR 
DISEASES. 
‘‘Not later than September 30, 2013, and annually 
thereafter, the Secretary of Health and Human Services 
shall prepare and submit to the Congress a report on the 
quality of and access to care for women with heart disease, 
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. 4. 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-
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lowing: ‘‘may make grants to such States for the 
purpose’’; and 
(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 $23,000,000 for fiscal year 2012, $25,300,000 
for fiscal year 2013, $27,800,000 for fiscal year 2014, 
$30,800,000 for fiscal year 2015, and $34,000,000 for 
fiscal year 2016.’’. 
Amend the title so as to read: ‘‘A bill to amend the 
Public Health Service Act to improve the prevention, di-
agnosis, and treatment of heart disease, stroke, and other 
cardiovascular diseases in women.’’. 
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Union Calendar No. 379 
111TH CONGRESS 
2D SESSION 
H. R. 1032 
[Report No. 111–639] 
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. 
SEPTEMBER 28, 2010 
Reported with amendments, committed to the Committee 
of the Whole House on the State of the Union, and or-
dered to be printed 
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