I 
112TH CONGRESS 
1ST SESSION H. R. 3526 
To amend the Public Health Service Act to improve women’s health by 
prevention, diagnosis, and treatment of heart disease, stroke, and other 
cardiovascular diseases in women, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 30, 2011 
Mrs. CAPPS introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to improve women’s 
health by prevention, diagnosis, and treatment of heart 
disease, stroke, and other cardiovascular diseases in 
women, and for other purposes. 
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’’. 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR 
DRUGS, BIOLOGICS, AND DEVICES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study investigating the ex-
tent 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 
subgroups. 
(b) REPORT BY GAO.— 
(1) SUBMISSION.—Not later than 12 months 
after the date of the enactment of this Act, the 
Comptroller General shall complete the study under 
subsection (a) and submit to the Committee on En-
ergy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, 
and 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 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
and following the guidance referred to in sub-
section (a). 
(B) A description of the effectiveness of 
the Food and Drug Administration’s enforce-
ment 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 gen-
der, 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 sub-
group is readily available to the public in a 
timely manner by means of the product label or 
the Food and Drug Administration’s Web site. 
(E) Appropriate recommendations for— 
(i) modifications to the requirements 
and guidance referred to in subsection (a); 
or 
(ii) oversight by the Food and Drug 
Administration of such requirements. 
VerDate Mar 15 2010 
01:55 Dec 01, 2011
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
(c) REPORT BY HHS.—Not later than 6 months 
after the submission by the Comptroller General of the 
report required under subsection (b), the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a response to such re-
port, including a corrective action plan as needed to re-
spond to the recommendations in such report. 
(d) BIENNIAL REPORTS BY THE FOOD AND DRUG 
ADMINISTRATION.—Not later than 2 years after the date 
of enactment of this Act, and every 2 years thereafter— 
(1) the Director of the Office of Women’s 
Health of the Food and Drug Administration 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 report that includes each of the elements 
described in subparagraphs (A) through (E) of sub-
section (b)(2), with respect to women’s health; and 
(2) the Director of the Office of Minority 
Health of the Food and Drug Administration shall 
submit to such Committees a report that includes 
each of such elements, with respect to minority 
health. 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
(e) 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)). 
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–6. REPORTING ON QUALITY OF AND ACCESS TO 
CARE FOR WOMEN WITH CARDIOVASCULAR 
DISEASES. 
‘‘Not later than September 30, 2014, 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, 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
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-
lowing: ‘‘may make grants to such States for 
the purpose’’; 
(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.’’; and 
(3) by adding at the end the following new sub-
section: 
‘‘(e) STUDY.— 
‘‘(1) The Secretary shall (directly or through 
grants or contracts) conduct a study of the impact 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS
of the Patient Protection and Affordable Care Act 
on the preventive health services, referrals, and fol-
low-up services described in subsection (a). 
‘‘(2) Not later than 18 months after the date 
of enactment of this subsection, the Secretary shall 
submit to the Committee on Energy and Commerce 
of the House of Representatives and to the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate a report containing the results of the 
study under paragraph (1) and recommendations for 
improving the provision of preventive health services, 
referrals, and follow-up services described in para-
graph (1) to women eligible for such services under 
grants funded under this section.’’. 
Æ 
VerDate Mar 15 2010 
01:14 Dec 01, 2011
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6301
E:\BILLS\H3526.IH
H3526
smartinez on DSK6TPTVN1PROD with BILLS