Senate - 11/15/2010 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)
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This bill has the status Passed House
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Introduced
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(
[actionDate] => 2010-09-28
[displayText] => Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-639.
[externalActionCode] => 5000
[description] => Introduced
[chamberOfAction] => House
)
Passed House
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(
[actionDate] => 2010-09-30
[displayText] => Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR 9/28/2010 H7189-7190)
[externalActionCode] => 8000
[description] => Passed House
[chamberOfAction] => House
)
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Shown Here: Referred in Senate (11/15/2010)
111th CONGRESS 2d Session
H. R. 1032
IN THE SENATE OF THE UNITED
STATES
November 15, 2010
Received; read twice and referred to the
Committee on Health, Education, Labor,
and Pensions
AN ACT
To amend 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 Representatives of the
United States of America in Congress assembled,
SECTION 1.Short title.
This Act may be cited as the
“Heart Disease Education, Analysis
Research, and Treatment for Women Act” or the
“HEART for Women
Act”.
SEC. 2. Report by
Government Accountability Office.
(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 devices comply with Food and Drug Administration requirements
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 Energy 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 paragraph (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 following 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 females, 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 manner by means of the product label or the Food and Drug
Administration’s Website.
(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.
(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
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)).
SEC. 3. Reporting on
quality of and access to care for women with cardiovascular
diseases.
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 follows through “purpose” and inserting the following:
“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 appropriated
$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.”.
Passed the House of Representatives September 30
(legislative day September 29), 2010.