S.Amdt. 2884

SA 2884. Ms. STABENOW (for herself, Mr. Kerry, Mrs. Boxer, Ms.
Klobuchar, Mr. Bayh, Mr. Lautenberg, and Mr. Johnson) submitted an
amendment intended to be proposed to amendment SA 2786 proposed by Mr.
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the
first-time homebuyers credit in the case of members of the Armed Forces
and certain other Federal employees, and for other purposes; which was
ordered to lie on the table; as follows:

At the end of title VII, insert the following:

Subtitle C--Heart Disease Education, Analysis Research, and Treatment
for Women

SEC. 7201. SHORT TITLE.

This subtitle may be cited as the ``Heart Disease
Education, Analysis Research, and Treatment for Women Act''
or the ``HEART for Women Act''.

SEC. 7202. REPORTING OF DATA IN APPLICATIONS FOR DRUGS,
BIOLOGICAL PRODUCTS, 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 sentence--
(i) by striking ``drug, and (G)'' and inserting ``drug;
(G)''; and
(ii) by inserting before the period the following: ``; and
(H) the information required under paragraph (7)''; and
(B) by adding at the end the following:
``(7)(A) With respect to clinical data in an application
under this subsection, the Secretary may deny such an
application 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 Web 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)(1) of this Act, subsection (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 secrets or
confidential commercial information.
``(D) The Secretary shall develop guidance for staff of the
Food and Drug Administration to ensure that applications
under this subsection are adequately reviewed to determine
whether the applications include the information required
pursuant to subparagraphs (A) and (B).''.
(2) Investigational new drug applications.--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
Regulations.
``(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 effectiveness of
the drug involved by gender, age, and racial subgroup.''.
(b) Biological Product License Applications.--Section 351
of the Public Health Service Act (42 U.S.C. 262), as amended
by section 7002, is further amended by adding at the end the
following:
``(n) The provisions of section 505(b)(7) of the Federal
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 and in the
same manner as such provisions apply with respect 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
application for premarket approval of a device under
subsection (c) of this section to the same extent and in the
same manner 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
individual study information) apply with respect to an
application 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).''.

[[Page S12419]]

(d) Rules of Construction.--This subtitle and the
amendments made by this subtitle 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 Cosmetic Act that are not expressly
referenced in this subtitle or the amendments made by this
subtitle.
(e) Application.--This section and the amendments made by
this section apply only with respect to applications 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. 7203. 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 product 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 analyses take into
account data that specifically relates to women and any
disparities between treatment and the quality of care between
males and females.''.

SEC. 7204. 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--
(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 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. 7205. 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
$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.''.
______